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Accepted Manuscript Title: Neonatal Early Warning Tools for recognising and responding to clinical deterioration in neonates cared for in the maternity setting: a retrospective case control study Authors: Michelle Paliwoda Karen New RN,RM,PhD Fiona Bogossian PII: S0020-7489(16)30076-1 DOI: http://dx.doi.org/doi:10.1016/j.ijnurstu.2016.06.006 Reference: NS 2767 To appear in: Received date: 4-11-2015 Revised date: 9-6-2016 Accepted date: 14-6-2016 Please cite this article as: Paliwoda, M., New, K., Bogossian, F.,Neonatal Early Warning Tools for recognising and responding to clinical deterioration in neonates cared for in the maternity setting: a retrospective case control study, International Journal of Nursing Studies (2016), http://dx.doi.org/10.1016/j.ijnurstu.2016.06.006 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Accepted Manuscript

Title: Neonatal Early Warning Tools for recognising andresponding to clinical deterioration in neonates cared for in thematernity setting: a retrospective case control study

Authors: Michelle Paliwoda Karen New RN,RM,PhD FionaBogossian

PII: S0020-7489(16)30076-1DOI: http://dx.doi.org/doi:10.1016/j.ijnurstu.2016.06.006Reference: NS 2767

To appear in:

Received date: 4-11-2015Revised date: 9-6-2016Accepted date: 14-6-2016

Please cite this article as: Paliwoda, M., New, K., Bogossian, F.,Neonatal Early WarningTools for recognising and responding to clinical deterioration in neonates cared for in thematernity setting: a retrospective case control study, International Journal of NursingStudies (2016), http://dx.doi.org/10.1016/j.ijnurstu.2016.06.006

This is a PDF file of an unedited manuscript that has been accepted for publication.As a service to our customers we are providing this early version of the manuscript.The manuscript will undergo copyediting, typesetting, and review of the resulting proofbefore it is published in its final form. Please note that during the production processerrors may be discovered which could affect the content, and all legal disclaimers thatapply to the journal pertain.

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Title 1 2 Neonatal Early Warning Tools for recognising and responding to clinical deterioration in neonates cared for 3 in the maternity setting: a retrospective case control study 4 5 6 Authors 7 8 Michelle Paliwoda 9 Affiliations: The University of Queensland, School of Nursing and Midwifery and The Royal Brisbane & 10 Women’s Hospital. 11 12 Dr. Karen New RN, RM, PhD 13 Affiliations: The University of Queensland, School of Nursing and Midwifery, UQ Centre of Clinical 14 Research and The Royal Brisbane & Women’s Hospital. 15 16 Associate Professor Fiona Bogossian 17 Affiliations: The University of Queensland, School of Nursing and Midwifery, UQ 18 19 20 Contact details 21 22 Michelle Paliwoda (Corresponding author) 23 Registered nurse 24 Grantley Stable Neonatal Nursery 25 L5 Ned Hanlon Building 26 Royal Brisbane and Women’s Hospital 27 Phone: (W) +61 7 3646 7846 28 Email: [email protected] 29 30 Dr Karen New 31 Midwifery Clinical Academic Fellow, RN, RM, PhD 32 UQ School of Nursing, Midwifery and Social Work 33 UQ Centre for Clinical Research | Royal Brisbane & Women's Hospital 34 Room 337, Level 3, Chamberlain Building, The University of Queensland QLD 4072 35 F: +61 7 3346 5599 36 Email: [email protected] 37 38 Associate Professor Fiona Bogossian 39 Director, Research Higher Degrees 40 School of Nursing, Midwifery and Social Work 41 Level 3, Chamberlain Building, The University of Queensland 4072 42 Email: [email protected] 43 44 Abstract 45

Background: All newborns are at risk of deterioration as a result of failing to make the transition to extra 46

uterine life. Signs of deterioration can be subtle and easily missed. It has been postulated that the use of an 47

Early Warning Tool may assist clinicians in recognising and responding to signs of deterioration earlier in 48

neonates, thereby preventing a serious adverse event. 49

50

Objective: To examine whether observations from a Standard Observation Tool, applied to three neonatal 51

Early Warning Tools, would hypothetically trigger an escalation of care more frequently than actual 52

escalation of care using the Standard Observation Tool. 53

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54

Design: A retrospective case-control study. 55

56

Setting: A maternity unit in a tertiary public hospital in Australia 57

58

Methods: Neonates born in 2013 of greater than or equal to 34+0 weeks gestation, admitted directly to the 59

maternity ward from their birthing location and whose subsequent deterioration required admission to the 60

neonatal unit, were identified as cases from databases of the study hospital. Each case was matched with 61

three controls, inborn during the same period and who did not experience deterioration and neonatal unit 62

admission. Clinical and physiological data recorded on a Standard Observation Tool, from time of admission 63

to the maternity ward, for cases and controls were charted onto each of three Early Warning Tools. The 64

primary outcome was whether the tool ‘triggered an escalation of care’. Descriptive statistics (n, %, Mean 65

and SD) were employed. 66

67

Results: Cases (n=26) comprised late preterm, early term and post term neonates and matched by gestational 68

age group with 3 controls (n=78). Overall, the Standard Observation Tool triggered an escalation of care for 69

92.3% of cases compared to the Early Warning Tools; New South Wales Health 80.8%, United Kingdom 70

Newborn Early Warning Chart 57.7% and The Australian Capital Territory Neonatal Early Warning Score 71

11.5%. Subgroup analysis by gestational age found differences between the tools in hypothetically triggering 72

an escalation of care. 73

74

Conclusions: The Standard Observation Tool triggered an escalation of care more frequently than the Early 75

Warning Tools, which may be as a result of behavioural data captured on the Standard Observation Tool and 76

escalated, which could not be on the Early Warning Tools. Findings demonstrate that a single tool applied to 77

all gestational age ranges may not be effective in identifying early deterioration or may over trigger an 78

escalation of care. Further research is required into the sensitivity and specificity of Early Warning Tools in 79

neonatal sub-populations. 80

81

Keywords: early warning tool, early warning score, newborn, maternity newborn care, neonate82

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83

Introduction 84

One of the greatest challenges a neonate must overcome is the transition to extrauterine life. All newborns 85

are at risk of deterioration as a result of failing to make this transition. Physiological immaturity, related to 86

gestational age, and the impact of infection on the immunologically immature neonate can alter the success 87

of adaptation (Ygberg & Nilsson, 2011; Graves & Haley, 2013). Signs of deterioration in the newborn can 88

be subtle and easily missed (Satar & Ozlu, 2012). It has been postulated by health authorities in Australia 89

and overseas that the use of an Early Warning Tool may help clinicians identify early signs of deterioration 90

and therefore respond promptly to prevent serious adverse events in acute health care settings (National 91

Patient Safety Agency, 2007; Clinical Excellence Commission, 2013; Paliwoda & New, 2015). 92

93

Early Warning Tools assist clinicians identify early deterioration by using a systematic process of charting 94

patient vital signs against pre-determined vital sign parameters (Australian Commission on Safety and 95

Quality in Health Care, 2012). Early Warning Tools vary in design but are generally coded with varying 96

colours or shades indicating worsening abnormal parameters, which is designed to alert the clinician by way 97

of set action prompts that an escalation of care is required (McLellan & Connor, 2013; Olroyd & Day, 2011; 98

Paliwoda & New, 2015). Other tools are based on scoring systems or a combination of both where if an 99

aggregate number exceeds a predetermined threshold an escalation process determines the clinician’s path of 100

intervention (Australian Commission on Safety and Quality in Health Care, 2012). 101

102

Safety and quality units of health care facilities worldwide have undertaken steps to assist clinicians 103

recognise and respond to clinical deterioration (National Health Service Trust, n.d; Institute for Healthcare 104

Improvement, 2016; An Roinn Slainte Department of Health, 2014). In 2010, the Australian Commission on 105

Safety and Quality Health Service mandated 15 standards to improve patient outcomes in acute health 106

settings of the 15; 10 apply to direct patient care (ACSQHS, 2010). Standard 9: Recognising and Responding 107

to Clinical Deterioration in Acute Health Care applies to all patients including babies cared for in maternity 108

health settings (ACSQHS, 2012). The study hospital has addressed this standard for adult and paediatric 109

clients by implementing Early Warning Tools (Queensland Government, 2012a). However, to date, an Early 110

Warning Tool has not been implemented for neonates. 111

112

The National Consensus Statement of Australia in 2010 recommended six key physiological observations: 113

respiratory rate, oxygen saturations, heart rate, blood pressure, temperature, and level of consciousness, be 114

incorporated into the development of Early Warning Tool to assist in identification of early deterioration 115

(ACSQHC, 2010). Importantly it could be argued that these ‘all population’ observations do not pertain to 116

newborns in the maternity ward, where presently key physiological observations such as blood pressure and 117

oxygen saturations are not routinely undertaken in the care of newborns in all maternity settings (Queensland 118

Government, 2012; King Edward Memorial Hospital, 2014). It could be further argued that newborn specific 119

observable behaviours that are indicative of deterioration, such as poor feeding, ‘spilling’, failing to wake for 120

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feeds, or falling asleep during feeding; and parental concern would be more applicable (Paliwoda & New, 121

2015; New South Wales Department of Health, 2011). In response to the Standard, a neonatal Early Warning 122

Tool is being developed for rollout across Queensland (Patient Safety Unit, Queensland Department of 123

Health, personal communication, May 29, 2015). While in other states of Australia, individual hospitals have 124

developed, adapted or introduced Early Warning Tools based on the all population key physiological data for 125

determining clinical deterioration (New South Wales Department of Health, 2012; New South Wales 126

Department of Health, 2013). 127

128

An earlier literature review found there is no ‘gold standard’ or validated early warning tool for use in 129

neonates, and studies in the adult, paediatric and neonatal population have demonstrated that the efficacy of 130

Early Warning Tool are mixed (Paliwoda & New, 2015). In light of this finding and the proliferation of 131

neonatal Early Warning Tool across Australia and internationally, we designed a retrospective case-control 132

study to examine and hypothetically compare the performance of three Early Warning Tools for neonatal use 133

in the maternity setting. 134

135

Objective 136

To examine whether observations from a Standard Observation Tool, applied to three neonatal Early 137

Warning Tools, would hypothetically trigger an escalation of care more frequently than actual escalation of 138

care using the Standard Observation Tool. 139

140

Materials and Methods 141

Study Design 142

A retrospective matched case control study. 143

144

Setting 145

A maternity unit in a tertiary public hospital in Australia. 146

147

Participants 148

Following ethical approval from institutional review boards, neonates inborn between January and December 149

2013, of greater than or equal to 34+0 weeks gestation, admitted directly to the maternity ward from their 150

birthing location (birth suite or operating theatre), were identified from databases of the study hospital. These 151

neonates were then categorised into their gestational age groups, i.e., late preterm (34+0-36+6), early term 152

(37+0-38+6), and post term (≥42+0) and from these groups the cases and controls were identified 153

(Supplementary Flowchart 1). The cases were those neonates deemed well and admitted to the maternity 154

ward but who subsequently deteriorated and required admission to the neonatal unit. All late preterm and 155

post term cases were included. A computer software program was used to randomly select a sample from the 156

early term cases, and then to randomly select three matched controls for each case in each age group. The 157

controls were neonates deemed well, admitted to the maternity ward, and subsequently discharged from the 158

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maternity ward without adverse event.159

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160

Instrumentation 161

162

Standard Observation Tool (SOT) 163

The study hospital uses a Vigilance and Baby Management Chart (referred to in this study as the Standard 164

Observation Tool), which was developed by the study hospital and to the best to our knowledge has not been 165

validated nor has its clinical effectiveness been examined. This tool is used routinely for all neonates at the 166

study hospital from the time of birth until discharge in all maternity settings (excluding the neonatal units). 167

The policy of the study hospital is that all neonates have observations every 15 minutes for the first two 168

hours in birth suites/centre. This includes oxygenation saturations and blood pressure monitoring prior to 169

discharge to the maternity ward. Once transferred to the maternity ward, newborns must have observations at 170

least eight hourly, although in the event of maternal risk factors, such as Streptococcus Group B colonisation 171

or an intrapartum event, the frequency of observations is increased (Queensland Government, 2012b). 172

173

The Standard Observation Tool allows for the documentation of routine physiological, clinical, and 174

behavioural observations such as respiration rate, heart rate, blood glucose level, method of feeding, volume 175

of feed consumed and documentation of elimination. Oxygenation saturations and blood pressure are not 176

routinely monitored in the maternity ward. The tool also incorporates a comments column, which allows for 177

documentation of objective observable behaviours such as irregular heartbeat, vomiting, distended abdomen, 178

and the degree to which the neonate is unsettled, inconsolable, grimacing (pain), or sleepy. The comments 179

column appears to facilitate the documentation of actions taken and/or escalation of care in response to any 180

abnormal physiological or behavioural observations. 181

182

Early Warning Tools 183

Despite the absence of a published, validated ‘gold standard’ neonatal Early Warning Tool (Paliwoda & 184

New, 2015), a number of Early Warning Tools are being used in neonates. However, we considered several 185

of these as not being suitable for neonates in maternity settings for reasons such as: a wide age range, for 186

example 0-3 months or 0-12 months; specific design for use in paediatric settings, or the set physiological 187

parameters fell outside the range for newborns (Dawson, Omar, Kamlin, Vento, Wong, Cole, Donath, Davis, 188

& Morley, 2010; King Edward Memorial Hospital, 2014, Fyfe, Yiallourou & Horne, 2012; Ching, Lavin & 189

Blair, 2011). Thus, for inclusion in this study the Early Warning Tools needed to be specific for the neonatal 190

age range (0-28 days) and have been implemented in neonatal settings in Australia or the United Kingdom. 191

The Early Warning Tools selected for this study have been evaluated following introduction into the clinical 192

setting (Clinical Excellence Commission, 2013; Roland, Madar, & Connolly, 2010; Australian Capital 193

Territory, 2013), though, to the best of the authors knowledge they have not been validated. The authors 194

were not involved in the construction of any of the Early Warning Tools included in this study, which are 195

summarised below and available in Supplement One. 196

197

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1) ACT Health ‘Newborn Early Warning Score’ (ACT NEWS) 198

The ‘Newborn Early Warning Score’ was developed by key stakeholders of the Centenary Hospital for 199

Women & Children and Calvary Bruce Private Hospital for Australian Capital Territory Health. It was 200

randomly audited following implementation in the postnatal environment and the results presented at the 201

2014 ‘Managing the Deteriorating Patient Conference’ (Kecskes, Ovington, & Slater, 2014). This tool 202

utilises a colour-coded (yellow, pale blue, light purple, dark purple) single parameter aggregate scoring 203

system which is designed for use in neonates aged between 0-<1 month post term and incorporates 204

subjective clinical assessment of respiratory effort and objective quantifiable data consisting of heart rate, 205

respiratory rate, oxygen saturation monitoring, and temperature. The frequency and duration of observations 206

are informed by the completion of a ‘newborn risk assessment’ that is part of this four-page document. It is 207

intended that this assessment be completed within one-hour of birth. Neonates with no identifiable risk 208

factors are required to have the minimum observations (12th hourly). If the neonate has an aggregate score of 209

greater than or equal to four, the tool provides prompts for escalation of care and clinical review. 210

211 2) New South Wales Health 212

The Clinical Excellence Commission developed the Between the Flags ‘Safety Net’ system in 2010 to enable 213

clinicians to identify signs of clinical deterioration and provide timely intervention to prevent a serious 214

adverse event and improve patient outcomes (Clinical Excellence Commission, 2013). The system 215

incorporates population specific Early Warning Tools, for example, adults (General, and Emergency), 216

paediatrics (under 3 months, 3 to 12 months, 1 to 4 years, 5-11 years, and over 12 years), maternity 217

(Standard Maternity and antenatal), and newborn (standard). The Standard Neonatal Observation Chart 218

(SNR110.014) is a single parameter colour-coded (blue, yellow, red) track and trigger system designed for 219

use in special care units and maternity settings for neonates under one month of corrected age (Clinical 220

Excellence Commission, 2012). The tool incorporates subjective clinical assessment of respiratory effort and 221

behaviour and objective quantifiable data consisting of heart rate, oxygen saturation monitoring, blood 222

pressure, temperature and blood glucose monitoring. When observations fall within one or more of the 223

colour-coded zones, instructions on the overleaf of this four-page tool provide details of the expected 224

escalation of care for each of the colour zones. 225

226

3) Newborn Early Warning Observation Chart (UK NEW) 227

Dr Damian Roland and Dr John Madar of the Plymouth Hospitals National Health Service Trust, United 228

Kingdom developed this Early Warning Tool (Roland, Madar, & Connolly, 2010). The Newborn Early 229

Warning Observation Chart is a single parameter colour-coded system of red, yellow, and green that prompts 230

escalation of care for clinical, physiological and observational data (heart rate, respiration rate, temperature 231

and oxygen saturations). Observations or symptoms that would indicate central nervous system or airway 232

compromise are additional assessable items charted using letters and can also trigger escalation of care. If all 233

observations are in the green zone, no escalation of care is required. If two or more observations are in the 234

yellow zone or one in the red zone, then immediate review is required. The clinical effectiveness and utility 235

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of this tool has been examined but not rigorously tested to assess reliability and validity (Roland, Madar, & 236

Connolly, 2010). 237

238

Data parameters 239 For this study, physiological observations were considered abnormal if they fell outside the normal reference 240

range of the study hospital protocol. In charting the observations from the Standard Observation Tool onto 241

each of the three other Early Warning Tools, it became apparent, with the exception of respiratory rate, there 242

is a lack of consensus on ‘normal’ reference ranges (Table 1). 243

244

Table 1: Normal physiological reference ranges for the Standard Observation Tool (SOT) and the three Early 245

Warning Tools 246

Observation SOT ACT NEWS NSW Health UK NEW

Respiration

≥30bpm

≤60bpm

≥30bpm

≤60bpm

≥30bpm

≤60bpm

≥ 30bpm

≤ 60bpm

Heart Rate

≥120 bpm

≤160bpm

≥ 90bpm

≤ 160bpm

≥ 110bpm

≤160bpm

≥ 90bpm

≤ 150bpm

Temperature

≥36.5°C

≤ 37.4°C

≥36.5°C

≤ 37.5°C

≥36.5°C

≤ 37.5°C

≥ 36.0 °C

≤ 37.2°C

Blood Glucose level

≤ 2.6mmol/L

≥15mmol/L Not indicated

≤ 3.0mmol/L

≥ 10mmol/L Not indicated

bpm – breaths per minute (respiration) or beats per minute (heart rate); C - Degrees Celsius; mmol/L - 247 Millimols per litre 248 249 “Triggered an escalation of care” 250 For this study, “triggered an escalation of care”, was deemed to be when; a physiological observation fell 251

outside of the normal range and/or, clinician notation of a behavioural observation which was actioned or 252

care escalated as documented on the Standard Observation Tool or in the clinical notes. For the Early 253

Warning Tools, ‘triggered an escalation of care’ was hypothetical but deemed to have occurred when; either 254

one or more charted observations fell in an abnormal zone or, the aggregate score reached the number which 255

triggered an escalation of care for the individual tool. Each Early Warning Tool indicates that in the event of 256

abnormal observation/s, observation frequency should be increased and/or repeated within 30 minutes. 257

Therefore, for this study, escalation of care for the Standard Observation Tool was deemed not to have 258

occurred if observations were not repeated within 30 minutes. 259

260

Data collection 261

Between April and June 2015, the first author retrieved the medical charts of cases and controls, collected 262

and charted the source data onto each of the three Early Warning Tools. The source data were the data 263

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documented on the Standard Observation Tool. However, the clinical notes were reviewed to confirm 264

whether an escalation of care or action was taken if this was not documented on the Standard Observation 265

Tool. If the source data or documentation in the clinical notes was unclear to the first author, the second 266

author reviewed the medical chart and consensus was obtained. The data were charted from the first recorded 267

observations on admission to the maternity ward until discharge to either the neonatal unit (case) or home 268

(control). 269

270

Data analysis 271

Data were entered into IBM SPSS data editor Version 22 (SPSS Inc., Chicago, IL). Descriptive statistics (n, 272

%, Mean and SD) were used to report differences between neonatal and clinical characteristics for cases and 273

controls and to determine the frequency of cases and controls triggering an escalation of care. 274

275

Results 276

Participant characteristics 277 Neonatal and clinical characteristics for the 26 cases: late preterm (n=8), early term (n=16), post term (n=2) 278

and 78 controls are presented in Table 2. As a surrogate marker for initial wellness, we report the majority of 279

cases had Apgar scores ≥7 at 1 and 5 minutes, as did controls. 280

281 Table 2: Neonatal and clinical characteristics at birth for cases and controls 282

LPT – Late preterm; ET – Early term; PT – Post term 283

284

Performance of the early warning tools 285

The performance of each of the early warning tools is reported according to their actual and hypothetical 286

incidence of triggering an escalation of care. Firstly, we report the summary of results for triggering an 287

escalation of care for cases and controls (Table 3). Followed by the cases that did or did not trigger an 288

escalation of care on the Standard Observation Tool, and whether these cases hypothetically triggered on 289

each Early Warning Tool (Table 4). We also report controls that either had an observation within the normal 290

Characteristics

Cases (n=26) Controls (n=78)

LPT (n=8) n (%)

ET (n=16) n (%)

PT (n=2) n (%)

LPT (n=24) n (%)

ET (n=48) n (%)

PT (n=6) n (%)

Sex Male 4 (50) 8 (50) 1 (50) 8 (33.3) 23 (47.9) 2 (33.3)

Female 4 (50) 8 (50) 1 (50) 16 (66.7) 25 (52.1) 4 (66.7) Weight (g) mean (± SD)

2845 (± 0.28) 3060 (± 0.42) 4845 (± 0.50) 2899 (± 0.31) 3154 (± 0.41) 3429 (± 0.33)

Type of Birth

Vaginal 5 (62.5) 8 (50) 0 (0) 12 (50) 18 (37.5) 5 (83.3) Caesarean

Section 3 (37.5) 8 (50) 2 (100) 12 (50) 30 (62.5) 1 (16.7)

APGAR (1 minute)

≤ 6 1 (12.5) 0 (0) 0 (0) 1 (4.2) 1 (2.1) 0 (0)

≥ 7 7 (87.5) 16 (100) 2 (100) 23 (95.8) 47 (97.9) 6 (100)

APGAR (5 minutes)

≤ 6 1 (12.5) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)

≥ 7 7 (87.5) 16 (100) 2 (100) 24 (100) 48 (100) 6 (100)

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reference range of the hospital or that did not trigger an escalation of care on the standard observation tool, 291

but hypothetically triggered on at least one Early Warning Tool (Table 5). 292

293

Table 3: Actual and hypothetical incidence of triggering an escalation of care for cases and controls by 294 gestational age group and tools 295

LPT – Late preterm; ET – Early term; PT – Post term; SOT – Standard Observation Tool 296

297

Of the 26 cases who were well and subsequently deteriorated, abnormal observations recorded on the 298

Standard Observation Tool triggered an escalation of care for 24 (92.3%) cases. The observations charted on 299

each of the three Early Warning Tools hypothetically triggered an escalation of care in between 3 to 21 (11.5 300

- 80.8%) of cases, depending on the respective tool (Table 3). Subgroup analysis by gestational age revealed 301

that the New South Wales Health Tool was hypothetically more responsive in triggering an escalation of care 302

for late preterm neonates than the Standard Observation Tool, and for all gestation age groups compared to 303

the other two Early Warning Tools (Table 3). 304

305

The observations of 78 controls were reviewed to ascertain the incidence of observations that did or did not 306

trigger an escalation of care by the Standard Observation Tool and whether these observations would have 307

hypothetically triggered an escalation of care on any of the Early Warning Tools. There were 32 (41.0%) 308

controls which had an observation recorded on the Standard Observation Tool in which the clinician 309

indicated an escalation of care. The number of control observations that hypothetically triggered an 310

escalation of care for each of the Early Warning Tools varied between 1.3 – 69.2% (Table 3). 311

312

Cases triggering an escalation of care 313 314 Cases that did or did not trigger an escalation of care were identified by the standard observation tool and 315

examined using each of the early warning tools (Table 4). 316

317

318

Gestational age group

SOT ACT NEWS

NSW Health

UK NEW

Yes n (%)

No n (%)

Yes n (%)

No n (%)

Yes n (%)

No n (%)

Yes n (%)

No n (%)

Cases (n=26)

LPT (n=8)

6 (77.0) 2 (25.0) 2 (25.0) 6 (75.0) 7 (87.5) 1 (12.5) 5 (62.5) 3 (37.5)

ET (n=16)

16 (100) 0 (0) 1 (6.3) 15 (93.8) 12 (75.0) 4 (25.0) 9 (56.3) 7 (43.8)

PT (n=2) 2 (100) 0 (0) 0 (0) 2 (100) 2 (100) 0 (0) 1 (50.0) 1 (50.0) TOTAL 24 (92.3) 2 (7.7) 3 (11.5) 23 (88.5) 21 (80.8) 5 (19.2) 15 (57.7) 11 (42.3)

Controls (n=78)

LPT (n=24)

8 (33.3) 16 (66.7) 0 (0) 24 (100) 13 (54.2) 11 (45.8) 9 (37.5) 15 (62.5)

ET (n=48)

22 (43.8) 26 (56.3) 1 (2.1) 47 (97.9) 38 (79.2) 10 (20.8) 15 (31.3) 33 (68.8)

PT (n=6) 2 (33.3) 4 (66.6) 0 (0) 6 (100) 3 (50.0) 3 (50.0) 0 (0) 6 (100) TOTAL 32 (41.0) 46 (59.0) 1 (1.3) 77 (98.7) 54 (69.2) 24 (30.8) 24 (30.8) 54 (69.2)

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Standard Observation Tool 319

Those observations identified by clinicians as outside of normal reference range by the study hospital, 320

triggered an escalation of care in 24 (92.3%) cases using the Standard Observation Tool. The two cases that 321

had no documentation of escalation of care were late preterm newborns, one with a heart rate of 180 beats 322

per minute and the other with a respiration rate of 148 breaths per minute (Table 4). 323

324 The Australian Capital Territory Neonatal Early Warning Score (ACT NEWS) 325

Of the 26 cases, the tool that hypothetically triggered an escalation of care the least was the Australian 326

Capital Territory Neonatal Early Warning Score. The observations triggered an escalation of care for three 327

neonates (11.5%), two late preterm (25.0%) and one early term (6.3%) (Table 3). Of these neonates, one 328

(Case 5) had an observation that entered the dark purple zone which hypothetically triggered a medical 329

emergency team call and the other two (Cases 8 and 22), had abnormal observations that when combined, 330

resulted in an aggregate score of ≥4 thereby hypothetically triggering an escalation of care (Table 4). The 331

remaining late preterm (n=6), early term (n=15), and post term (n=2) cases in which the abnormal 332

observations did not trigger an escalation of care were a result of the pre-determined aggregate score for 333

escalation not being reached. In addition, this tool does not measure a number of physiological (e.g. blood 334

glucose level), clinical (e.g. vomiting) and behavioural observations (e.g. sleepy and not feeding), resulting 335

in the tool potentially not identifying subtle signs of deterioration for 11 of the cases (Table 4). 336

337

New South Wales Health Early Warning Tool (NSW Health) 338

Of the three Early Warning Tools, the New South Wales Health Early Warning Tool hypothetically triggered 339

an escalation of care for the majority of cases (n=21; 80.8%). This tool hypothetically triggered an escalation 340

of care for 100% of post term cases, 75% of early term cases and identified one additional late preterm 341

neonate compared to the Standard Observation Tool (Table 3). The four early term cases (10, 11, 14, and 16) 342

did not trigger because, as for the previous tool, clinical and behavioural observations have not been 343

incorporated into the design of this Early Warning Tool. 344

345 United Kingdom Newborn Early Warning Chart (UK NEW) 346

The United Kingdom Newborn Early Warning Chart hypothetically triggered an escalation of care for just 15 347

(57.7%) of the 26 cases (Tables 3 and 4). Like the Australian Capital Territory Neonatal Early Warning 348

Score tool, this tool does not facilitate blood glucose levels to trigger an escalation of care and as such, the 349

majority of cases that did not trigger across all gestational age groups were for low blood glucose levels 350

(Cases 3, 6, 7, 13, 15, 17, 19 and 26, Table 4). Likewise, physiological observations such as vomiting did 351

not trigger (Cases 10 and 14) and a tolerance for mild hypothermia, accepting axillary temperatures as low as 352

36.0°C, did not trigger an escalation of care for one neonate (Case 20). 353

354

355

356

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Table 4: Cases that did or did not trigger an escalation of care by Standard Observation Tool and Early 357 Warning Tool 358

GA – Gestational age; LPT – Late preterm; ET – Early term; PT – Post term; GA -gestational age; T-359 Temperature BGL – Blood glucose level; RR – respiration rate; HR – Heart rate; EOC – Escalation of Care; 360 SOT – Standard Observation Tool 361 362

363

364

365

366

367

368

Case (N=26)

GA Observation

Actual trigger of

EOC Hypothetically triggered an EOC

SOT ACT

NEWS NSW

Health UK

NEW

1 LPT T: 37.5C Yes No No Yes

2 LPT Increased respiratory effort Yes No Yes Yes

3 LPT BGL: 2.6mmol/L Yes No Yes No

4 LPT HR: 180 bpm [RR 50 bpm; T: 37.3C] No No Yes Yes

5 LPT RR: 148 bpm [HR: 140 bpm; T:36.6C] No Yes Yes Yes

6 LPT BGL: 1.9mmol/L Yes No Yes No

7 LPT BGL: 2.6mmol/L Yes No Yes No

8 LPT RR 24bpm; Respiratory effort; T:36.4C Yes Yes Yes Yes

9 ET HR: 80 bpm Yes No Yes Yes

10 ET Mucous vomits Yes No No No

11 ET Irregular HR Yes No No Yes

12 ET HR: 98 bpm; T: 36.3C Yes No Yes Yes

13 ET BGL: 2.1mmol/L Yes No Yes No

14 ET Vomiting Yes No No No

15 ET BGL: 1.4mmol/L Yes No Yes No

16 ET Baby sleepy, not feeding Yes No No Yes

17 ET BGL: 2.4mmol/L Yes No Yes No

18 ET Increased respiratory effort Yes No Yes Yes

19 ET BGL: 1.4mmol/L Yes No Yes No

20 ET T: 36.4C Yes No Yes No

21 ET Dusky episode Yes No Yes Yes

22 ET RR: 80 bpm; T: 36.4C Yes Yes Yes Yes

23 ET Respiratory effort Yes No Yes Yes

24 ET Dusky episode Yes No Yes Yes

25 PT T: 38.2C Yes No Yes Yes

26 PT BGL: 2.4mmol/L Yes No Yes No

Total n (%) 24 (92.3) 2 (7.7) 21 (80.8) 15 (57.7)

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Controls triggering an escalation of care 369

Of the 78 controls, 44 had observations that were within the normal reference range of the study hospital 370

thereby not requiring any escalation of care. The remaining 34 controls had either an observation that ought 371

to have triggered an escalation of care by the Standard Observation Tool (n=22) or an observation that was 372

within the normal reference range of the hospital (n=12). At least one of the Early Warning Tools 373

hypothetically triggered an escalation of care for each of the 34 controls (Table 5). 374

375

Standard observation tool 376

The 22 (64.7%) controls for which there was no escalation of care documented on the Standard Observation 377

Tool (nor in the clinical notes) were for observations such low or high temperatures (n=16, 47.1%), heart 378

rate (n=3, 8.8%), respiratory (n=1, 2.9%), or a multiple of observation (n=2, 5.9%). 379

380

Early warning tools 381

Of the 34 controls, the New South Wales Health Early Warning Tool hypothetically triggered an escalation 382

of care for 27 (79.4%) controls; the United Kingdom Newborn Early Warning Chart for 12 (35.3%) and the 383

Australian Capital Territory Newborn Early Warning Score just one (2.9%). 384

385

While the New South Wales Health Early Warning Tool was responsive to hypothetically triggering an 386

escalation of care for cases it was also responsive for controls, triggering an escalation of care for seven 387

(70%) late preterm controls, 19 (82.6%) early term and one post term control (Table 5). The triggering 388

observations were temperature variations (n=15, 44.1%); blood glucose levels (n=6, 17.6%); heart rate (n=3, 389

8.8%); respiratory (n=1, 2.9%); or a multiple of observations (n=2, 5.9%). The United Kingdom Newborn 390

Early Warning Chart was less responsive to triggering an escalation of care across all gestational age groups: 391

(late preterm (n=3, 30%), early term (n=9, 39.18%) and no post term, and the triggering observations were 392

similar to that of the New South Wales Health Early Warning Tool with the exception of blood glucose 393

levels (Table 5). While the Australian Capital Territory Newborn Early Warning Score hypothetically 394

triggered an escalation of care for just one early term control (Control 22). This set of observations (Control 395

22) hypothetically triggered on all of the Early Warning Tools, but no action was charted on the Standard 396

Observation Tool or in the clinical notes (Table 5). However, given the significance of these observations 397

and that this neonate remained a control infant, one may theorise that the observation parameters were 398

inadvertently charted in the reverse columns. That is, the heart rate was recorded in the respiratory rate 399

column and vice versa. Conversely the Australian Capital Territory Newborn Early Warning tool did not 400

trigger for a temperature of 39.9oC (RR: 42bpm and HR:132bpm) (Control 19), nor was this escalated on the 401

Standard Observation Tool. Likewise given this neonate remained a control and with no documentation in 402

the clinical notes indicating there was a problem, we speculate that this may have also been a documentation 403

error. 404

405

406

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Table 5: Controls that did or did not trigger an escalation of care on the Standard Observation Tool and by 407 Early Warning Tool 408

409

Controls (n=34)

GA

Observation

Did Not Trigger an EOC

Hypothetically triggered an EOC

SOT ACT NEWS

NSW Health

UK NEW

1 LPT BSL: 2.9mmol/L NRR No Yes No

2 LPT T: 36.4C No No Yes No

3 LPT T: 36.3C No No Yes No

4 LPT BGL: 2.8mmol/L NRR No Yes No

5 LPT T: 37.5C No No No Yes

6 LPT BGL: 2.9mmol/L NRR No Yes No

7 LPT T: 37.3C NRR No No Yes

8 LPT T: 36.4C No No Yes No

9 LPT T: 37.3C NRR No No Yes

10 LPT T: 36.4 No No Yes No

11 ET T: 36.4C; RR: 66bpm No No Yes Yes

12 ET T: 36.3C No No Yes No

13 ET T: 36.4C No No Yes No

14 ET T: 36.2C No No Yes No

15 ET HR 155bpm NRR No No Yes

16 ET BGL 2.9mmol/L NRR No Yes No

17 ET T: 36.4C No No Yes No

18 ET HR: 160bpm NRR No No Yes

19 ET T: 39.9C [RR: 42bpm, HR:132bpm] No Yes Yes Yes

20 ET HR: 105bpm No No Yes No

21 ET RR: 62bpm No No Yes Yes

22 ET HR: 40bpm; RR: 120bpm No Yes Yes Yes

23 ET T: 36.4C No No Yes No

24 ET BGL: 2.6mmol/L NRR No Yes No

25 ET HR: 100bpm No No Yes No

26 ET HR: 166bpm No No Yes Yes

27 ET T: 36.3C No No Yes No

28 ET T: 37.3C NRR No No Yes

29 ET T: 36.4C No No Yes No

30 ET T: 36.3C No No Yes No

31 ET T: 36.3C No No Yes No

32 ET HR: 156bpm NRR No No Yes

33 ET BSL: 2.8mmol/L NRR No Yes No

34 PT T: 36.3C No No Yes No

Total n (%) 22 (64.7%) 2 (5.9) 27 (79.4) 12 (35.3)

410 LPT – Late preterm; ET – Early term; PT – Post term; GA -gestational age; BGL – Blood glucose level; RR 411

– respiration rate; bpm – breaths per minute; HR – Heart rate; bpm – beats per minute; T-Temperature; EOC 412

- escalation of care; NRR – normal reference range at the study hospital; SOT – Standard Observation Tool 413

414

415

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Discussion 416

The objective of this study was to examine whether observations from the Standard Observation Tool, 417

applied to three neonatal Early Warning Tools, would hypothetically trigger an escalation of care more 418

frequently than escalation of care using a Standard Observation Tool. Overall, for cases, the three neonatal 419

Early Warning Tools used in this study did not trigger an escalation of care more frequently than the 420

Standard Observation Tool. Although by gestational age group, one tool, the New South Wales Health Early 421

Warning Tool hypothetically triggered one additional case than the Standard Observation Tool. These 422

findings show that the design and measurement of observations in an early warning tool affects the 423

performance of the tool. 424

425

For the controls who had an abnormal observation and for whom the Standard Observation Tool escalated 426

care, none of the Early Warning Tools identified all of these abnormal observations. Nevertheless, for those 427

controls who had abnormal observations and the Standard Observation Tool did not escalate care, the New 428

South Wales Health Early Warning Tool hypothetically triggered an escalation of care considerably more 429

frequently than either of the other two tools (Table 5). However, the majority of the observations triggering 430

an escalation of care fell within the zone directing actions to an increase in frequency of observations and 431

allowing the clinician to make judgement as to whether there is a trend suggesting deterioration and the need 432

for a clinical review. Similarly, the majority of observations on the Standard Observation Tool may have 433

been assessed as part of the overall picture of the neonate and in the clinician’s opinion, not in isolation a 434

sign of deterioration. For example, in an instance of a high heart rate, ‘crying’ was noted on the Standard 435

Observation Tool for that observation and the subsequent observation was within normal range. 436

Additionally, for this study, we deemed that an escalation of care did not occur if observations were not 437

repeated within 30 minutes. However, for most abnormal observations, the frequency of observations were 438

increased, often being repeated within one to three hours. This may reflect the reality of current workloads in 439

busy maternity wards. Arguably, tools that are too responsive can potentially have a negative impact by 440

increasing workloads further of both nursing and medical personal when intervention was not required 441

(Cuthbertson & Smith, 2007). 442

443

Design of Early Warning Tools 444

The three Early Warning Tools tested in this study demonstrated mixed results with cases and controls, 445

despite being similar in a number of design features such as incorporating contrasting colours to indicate 446

worsening abnormal observations and providing specific action prompts once the escalation criterion was 447

met. Notably each tool has implemented varying colour combinations to draw attention to worsening 448

observations. However, traditionally, the green (stable), yellow (caution) and red (danger) combination is 449

used in many instances in the health care industry for tracking progress (Parker, n.d), in related health 450

projects and even the ‘traffic light’ system (New South Wales Government, 2015), the rationale for the 451

choice of other colour combinations in these tools are unknown. The results of this study suggest there are 452

three key differences between the tools: the scoring system used, measurement of additional observations 453

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(blood glucose levels and clinical observations), and differing physiological parameters. These differences 454

may have attributed to the performance of each of the tools. 455

456

Scoring system 457

The tools that hypothetically triggered an escalation of care more frequently in response to observations that 458

entered an abnormal zone, used a single parameter colour-coded system. The Australian Capital Territory 459

Newborn Early Warning Score had a requirement of an aggregate score. This reduced the number of cases 460

being triggered because even though the observations entered the abnormal coloured zone, the escalation 461

criterion is such that further escalation of care was not required. These results are in keeping with literature 462

that suggests that this method experiences a reduced level of responsiveness as a number of observations 463

need to be in abnormal zones prior to an action being triggered (Australian Commission on Safety and 464

Quality in Health Care, 2012). This has implications for clinical practice because, for example, in the early 465

stages of shock, the neonate can maintain a degree of compensation, thereby not displaying obvious, if any, 466

derangement of vital signs (Polin, Fox, & Abman, 2011; Sinniah, Subramaniam, & Soe-Hsiao, 2013; 467

Buonocore, Bracci, & Weindling, 2012). Perhaps, by the time multiple observations fall within the abnormal 468

zone triggering an escalation of care a serious adverse event may have already taken place. 469

Physiological reference ranges 470

There are significant physiological and neurological differences between the gestational age groups (Engle, 471

Tomashek & Wallman, 2007). It could be argued that what may be appropriate reference ranges for a post 472

term neonate, may in fact be indicative of compromise in the late preterm neonate and setting parameters 473

with a broad range may not be sufficient nor effective in capturing deterioration in neonates as a collective 474

cohort (Van Kuiken & Huth, 2013). There was some evidence of this in this study due to the variance in 475

parameter ranges, thereby no escalation of care for cases and an over-escalation for controls within the 476

respective gestational age groups. This highlights the need for standardised physiological parameters for 477

gestational age groups in the neonatal period (Mattson & Smith, 2011; Verklan & Walden, 2015; Takayama, 478

Wang, Uyemoto, Newman, Pantell, 2000) and importantly this may improve the sensitivity and specificity of 479

Early Warning Tools. Currently a one-size-fits all approach may not be suitable for newborns in the 480

maternity setting as reflected by the individual performance of the tools tested in this study, and in this 481

population where there were variations in the set physiological ranges such as heart rate, temperature, and 482

blood glucose levels. Previous studies have suggested that the cut off for parameters is based on clinical 483

intuition and/or historical data rather than on rigorously gathered data (Cuthbertson & Smith, 2007). The 484

effect of gestational age on physiologic parameters, for example, variations in heart rate between gestational 485

age groups has been documented (Fyfe, Yiallourou & Horne, 2012; Van Kuiken & Huth, 2013). 486

487

Heart rate 488

The Autonomic Nervous System (sympathetic and parasympathetic systems) controls cardiac functions such 489

as heart rate, heart rate variability and blood pressure. Lack of control due to immaturity is demonstrated in 490

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the late preterm neonate by their exhibiting a higher resting heart rate (Fyfe, Yiallourou & Horne, 2012). On 491

the other hand, post term neonates can exhibit a lower base line heart rate (Fyfe, Yiallourou & Horne, 2012). 492

This variability precludes one set of heart rate parameters across gestational ages and hence, it is necessary to 493

standardise heart rate, by gestational age group within the neonatal population (Van Kuiken & Huth, 2013). 494

495

Temperature 496

Newborns do not have the necessary thermoregulatory mechanisms to maintain body temperature and are at 497

risk of temperature instability due to a larger body surface area to weight ratio, reduced subcutaneous fat 498

stores, and an immature sympathetic nervous system which inhibits the neonate from initiating behaviours to 499

rectify being cold, such as ‘shivering’ (Brown & Landers, 2011). The United Kingdom Newborn Early 500

Warning Chart included a normal temperature range dissimilar to the other Early Warning Tool tested and 501

did not trigger an action for the case neonates who had lower temperatures. Moreover, it triggered an action 502

for controls who exhibited temperatures over 37.2ºC, which in clinical practice at the study hospital, is 503

regarded within normal temperature range, not indicative of sepsis and as such, requires no clinical 504

intervention. Therefore, in order for a tool to be effective, standardised parameters should be identified to 505

ensure deviating vital signs of neonates are captured (Cuthbertson, & Smith, 2007; Van Kuiken & Huth, 506

2013). If physiological reference ranges are set too conservatively, this would result in the tool being overly 507

responsive. A consequence of this would be increased frequency of referral for review, increased clinical 508

workload and potentially delayed discharge; all due to the neonate waiting for a clinical review. Equally, if 509

the ranges were set liberally, as demonstrated by The United Kingdom Newborn Early Warning Chart for 510

temperature, this may result in the tool being less responsive resulting in cases being missed. 511

512

Blood Glucose Levels 513

The only Early Warning Tool tested in this study that incorporated blood glucose level monitoring was the 514

New South Wales Early Warning Tool. To date, as with other physiological parameters, there is no defined 515

range for blood glucose levels, even though traditionally there appears to be agreement in the literature that 516

suggests intervention should begin when the blood glucose level is at or below 2.6mmol/L (Tin, 2014). Our 517

results suggest that by incorporating the blood glucose level, the New South Wales tool identified more cases 518

compared to the other Early Warning Tools. On the other hand, this tool had a normal blood glucose level 519

range between ≥3.0 and ≤10mmol/L. This conservative reference range triggered an escalation of care for a 520

number of controls exhibiting blood glucose levels ≥2.8mmol/L, which is considered normal at the study 521

hospital. 522

523

Behavioural observations 524

This study identified a number of observations in the case group that were not physiologically deranged vital 525

signs but clinical observations such as vomiting (with or without mucous), sleepiness and not feeding. 526

Moreover, these clinical observations were not included in the six physiological observations recommended 527

by the Australian Commission on Quality Safety Health Care yet triggered an escalation of care due to the 528

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concern of the clinician. Emerging research from the United Kingdom suggests that the gut instinct or 529

clinician intuition or concern regarding the patient is almost as effective as assessment of vital signs alone in 530

identifying the need for admission to the acute health setting (D. Roland, personal communication, 531

December 18, 2014). Therefore, it is vital that the design of an Early Warning Tool incorporates the ability 532

for the clinician to notate and escalate their concerns when required. 533

534

Clinical observable behaviours 535

The Standard Observation Tool incorporates a free text space that allows documentation of changes or 536

concerns with the newborns behaviour. For example, an irregular heartbeat, urine output, bowel motions, 537

vomiting, distended abdomen, the degree of being unsettled (inconsolable), grimacing (pain), and/or 538

sleepiness. The only early warning tool to incorporate elements of behaviour was the United Kingdom Tool, 539

which allowed documentation of behaviours and incorporated escalation processes depending on the 540

coloured zone the observation entered. 541

542

Strengths and limitations 543

A strength of this study is that a Neonatal Early Warning Tool designed in the United Kingdom and two 544

designed by different health authorities in Australia were compared to a Standard Observation Tool, which 545

has traditionally been used in the maternity ward for all neonates post birth at the study hospital. We 546

compared tools based on single parameter colour coded track and trigger system and an aggregate score 547

system and to the best of our knowledge, this is the first study of its kind in neonates in maternity settings. 548

549

While the data applied to the Early Warning Tools was from a retrospective data source, the data itself was 550

captured at the time of being documented. Even though both retrospective and prospective data may suffer 551

biases (Pannucci & Wilkins, 2010), to minimise bias due to seasonal variations and staff changes we 552

sampled all late preterm and post term neonates and a random selection of early term neonates, deemed well 553

who deteriorated in the maternity setting over a 12-month period. However, a limitation of this study and a 554

weakness of studies relying on retrospective data is that it can be incomplete and the validity of the data is 555

difficult to verify. Therefore, we were unable to verify several sets of observations that we surmise were 556

recorded in the wrong column. Due to a lack of documentation and the passing of time nor could we verify if 557

an escalation of care did or did not take place for both cases and controls with abnormal observations. 558

559

Conclusion 560

This study compared three Early Warning Tools designed for use for neonates cared for in the maternity 561

setting. Although the concept of an early warning tool is viewed as a positive step in the safe care and 562

management of neonates, the results of this study demonstrate that overall, the three Early Warning Tools 563

tested did not trigger an escalation of care more frequently than that of the Standard Observation Tool for 564

either cases or controls. Subgroup analysis by gestational age revealed differences between the tools in 565

frequency of triggering an escalation of care. However, the findings demonstrate that the design and 566

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measurement of observations in an early warning tool and the lack of standardised physiological reference 567

ranges affects the performance of the tools and it can be argued that one early warning tool ‘does not fit all’. 568

Consequently, several tools for specific gestational age groups of neonates may need to be developed if Early 569

Warning Tools are to be effective in detecting and triggering an escalation of care for early deterioration in 570

the newborn. Further research is needed into the normal physiological ranges of the gestational age groups 571

and the effectiveness of Early Warning Tools in these neonatal sub-populations. 572

573

574

575

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576

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