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An evidence-based approach to

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Written by Sue Lyon, Medical Writer & Editor

newborn skin cleansing

UNDERSTAND

NEWBORN

SKIN

2

Introduction

Current evidence and opinion

02 Current evidence and opinion

04 Understanding newborn skin

05 The importance of effective skin cleansing

07 New evidence on infant cleansing

08 Conclusions

08 References

Skin cleansing is essential for good health, but is especially relevant to infants, whose skin needs special care because of its developing structure, function and composition (Stamatas et al, 2011). Establishing good practice from birth is a foundation for healthy skin throughout life, but approaches to infant skin care are often based on tradition, personal experience and cultural factors (Ness et al, 2013). Family and friends can influence approaches to infant skin care, but parents are also likely to turn to health professionals such as midwives as trusted sources of information and advice (Lavender et al, 2009).

Current UK clinical guidelines recommend bathing newborns in water alone, using a mild, non-perfumed soap where required (NICE 2006). However, water has been shown to irritate and dry the skin (Tsai and Maibach 1999), and some health professionals and women are sceptical about its effectiveness as a cleanser when it is used alone (Lavender et al, 2009). Soap cleanses the skin, but it has been shown to impair the integrity of the skin barrier and its use has been cited as one of the most important factors in rising rates of atopic dermatitis in infants (Cork et al, 2009).

The current inconsistencies between evidence and national guidelines on newborn skin care have resulted in inconsistencies in professional practice and advice to mothers (Lavender et al, 2009; Walker et al, 2005). The result has been confusion among parents, who may choose skin care products for their baby on the basis of trial and error rather than evidence (Lavender et al, 2009).

It is important for health professionals such as midwives to be aware of both the evidence base on newborn cleansing and the need to provide women with an honest and clear picture where possible, allowing them to make their own decisions about their choices (Bedwell and Lavender, 2012). This supplement examines the latest research on the skin barrier in infants, and discusses recently published evidence and clinical studies researching best practice in infant skincare. The latest data provides evidence that the specially formulated, mild and gentle, pH-neutral cleansers investigated in these studies are safe and effective when used to cleanse newborn skin (Lavender et al 2012, Lavender et al, 2013).

The National Institute of Health and Care

Excellence (NICE) is a key national organisation

for any healthcare professional, including

midwives, looking for evidence-based guidance.

NICE published guidelines on the routine

postnatal care of women and their babies in

July 2006 (NICE 2006). In the brief section on

routine skin care, NICE recommends against

adding cleansing agents to a baby’s bath water

or using lotions or medicated wipes, and the

only cleansing agent suggested was a mild,

non-perfumed soap. However, these current

NICE guidelines on routine newborn skincare

are based on expert opinion, rather than clinical

evidence.

When formulating guidelines, NICE aims to

determine the most effective and cost-effective

care, based on a careful review of the best

available evidence (NICE 2006). NICE reviews

the quality of each clinical trial or other type

of evidence and then assigns a value or level.

In this hierarchy, high-quality randomised

controlled trials provide the best or level-1

evidence, followed by systematic reviews, case-

control or cohort studies (level 2), case reports

or case series (level 3), and expert opinion or

formal consensus (level 4) (NICE 2006).

NICE reviewed the evidence base for the

routine postnatal care guidelines between 2004

and 2006 (NICE 2006). At that time, NICE

was unable to find any research studies on the

general care of newborn skin (Dermott et al,

2006). Consequently, this latest NICE guidance

on routine infant skin care was a good practice

Contents

3

point (level-4 evidence) based on the

opinion of the experts in the guideline

development group rather than on level-1

evidence from randomised controlled

trials (Dermott et al, 2006).

Since 2012, new evidence on newborn

skin care has become available following

the publication of two large randomised

controlled trials (Lavender et al, 2012;

Lavender et al 2013). These findings

may be used to inform evidence-based

practice.

CONTINUING DEBATE

In addition, other experts have

come to further conclusions about

optimum infant skin care. In 2009, a

European Round Table panel of expert

dermatologists and paediatricians

published evidence-based, consensus

advice on routine infant cleansing

during the first year of life. After a

comprehensive review of the evidence,

the group recommended using mild,

thoroughly tested liquid cleansers rather

than water alone for newborn cleansing.

They advised against using water alone

or soap and water, citing evidence that

these approaches are associated with

adverse effects on infants’ skin, including

dryness, irritation and atopic dermatitis

(Blume-Peytavi et al, 2009).

The US Association of Women’s

Health, Obstetric and Neonatal Nurses

(AWHONN) has also reviewed evolving

evidence on neonatal skin care. In

the third, 2013 edition of its clinical

practice guideline, AWHONN provides

evidence-based recommendations on

protecting the newborn’s delicate skin

and promoting an intact and healthy

skin barrier (AWHONN 2013). This

comprehensive, practical guideline

includes detailed advice on routine

bathing procedures and choice of

cleanser, recommending use of skin

cleansers that have minimal impact on

a baby’s skin surface pH. The guideline

also includes practical advice that

midwives may find helpful when parents

seek advice on choosing a cleanser for

their baby’s skin.

Other authors have considered the

evidence and joined the debate on

newborn cleansing. A review of studies

published between 2000 and 2010

reported no harmful effects on skin

from either water or wash products

during the first year of life (Crozier

and Macdonald 2010). More recently, a

similar analysis found that daily bathing

with specially formulated products has

no negative effects on normal skin or

skin showing erythema, indurations or

dryness (Blume-Peytavi et al, 2012). A

second group of authors subsequently

concluded that the safest cleansing

products for full-term newborns are mild,

neutral-pH cleansers without added dyes

or fragrances (Ness et al, 2013).

Given the current lack of expert

consensus and evidence-based national

guidance for healthcare professionals, it

is not surprising that there is ‘informed

uncertainty’ among midwives, who

draw on tradition, experience and

opinion to inform their clinical practice

(Lavender et al, 2009). The result is

confusion among mothers, who may not

reveal that they disregard professional

advice and use baby skin care products

(Lavender, et al 2009). This may be

especially the case for women who lack

confidence in the effectiveness of water

alone when faced with the practical

realities of dealing with a soiled nappy

(Furber et al, 2012).

WHY ARE RANDOMISED CONTROLLED TRIALS IMPORTANT? Randomised controlled trials are regarded as the gold-standard method of evaluating the effectiveness of a treatment or other intervention. These trials have several important features:

• Random allocation of trial participants to intervention and control groups to eliminate any bias and ensure that the treatment group is as similar as possible to the control group

• Participants and investigators should remain unaware of which treatment was given (‘blinded’) until the study is completed, although such double-blind studies are not always feasible or appropriate

• All intervention groups are treated identically except for the experimental treatment

• Participants are normally analysed within the group to which they were allocated irrespective of whether they experienced the intended intervention (called intention- to-treat analysis)

• The analysis of the trial results focuses on estimating the size of any difference between intervention groups according to predefined outcomes

Based on: Akobeng 2005

CHOOSING CLEANSERS FOR NEWBORN SKIN (AWHONN 2013)

• The role of cleansers is to emulsify oil, dirt and micro-organisms on the skin surface so that they can easily be removed by water

• Ideally, cleansers should not cause skin irritation, disrupt the normal pH of the skin surface, or cause stinging or irritation of the eyes

• Select mild lipid cleansers or cleansing bars that have a neutral or mildly acidic pH (pH 5.5-7.0) or those that have been shown to have minimal impact on the baby’s skin surface pH

• Choose cleansers with preservatives that have demonstrated safety and tolerability for newborns. Preservatives are usually needed to prevent the overgrowth of micro-organisms that may occur with normal use, but they may result in skin irritation or contact dermatitis

4

The largest organ in the body, the

skin consists of three main layers: the

subcutis or inner-most fatty layer, the

dermis and the epidermis or outer layer.

The epidermis is continually regenerated

as new skin cells or keratinocytes form

in the stratum germinativum or basal

layer (McGrath et al, 2008). As the

keratinocytes move towards the surface

of the skin, they become flattened and

gradually die (McGrath et al, 2008).

The dead cells are called corneocytes

and make up the stratum corneum.

This cornified or ‘horny’ layer on the

surface of the skin is constantly shed

and replenished, and acts as a barrier,

preventing penetration by infectious

agents, irritants and allergens, while

regulating loss of water and nutrients

from the body (Stamatas et al, 2011).

The thinnest skin on a newborn is on

the face and as a result this is where

problems can first arise.

THE SKIN BARRIER IN INFANTSAlthough full-term babies have a fully

functioning skin barrier that prevents

organ dehydration, their skin is not yet

mature and continues to change and

develop during the first year of life

(Stamatas et al, 2011; Telofski et al, 2012).

As a result, infant skin is not as resilient

as adult skin (Blume-Peytavi et al, 2012),

and its unique properties should be

taken into account in order to maintain

the integrity of the infant skin barrier

(Stamatas et al, 2010).

The barrier properties of the skin depend

greatly on the thickness and integrity

of the stratum corneum (Telofski et al,

2012). At birth the stratum corneum is

30% thinner in full-term infants than

in adults (Stamatas et al, 2010). The

stratum corneum continues to develop

during the first year of life, when there

are important changes in skin hydration,

surface pH and permeability to water

measured as transepidermal water loss

(TEWL) (Nikolovski et al, 2008).

Full-term newborns have relatively dry

skin, which becomes more hydrated than

adult skin during the first four weeks of

life (Telofski et al, 2012). At the same

time, although skin is more hydrated in

infants than in newborns, it has greater

TEWL and a lower concentration of

natural moisturising factors, surface

lipids and sebum compared to the skin

of newborns or adults (Stamatas et al

2011; Telofski et al, 2012). This means that

a skin cleansing regimen for newborns

must be able to remove unwanted

material from the skin without inducing

dryness, irritation, itch and barrier

damage (Stamatas et al, 2012).

The pH of any newborn cleansing regimen

is another important consideration

because of changes in the skin acidity

or ‘acid mantel’ of newborns (Stamatas

et al, 2011). At birth, the skin surface in

full-term newborns has a neutral pH of

6.34-7.5. This falls in the first two weeks

of life to become more acidic at pH 5.0,

similar to the skin surface pH of 4.0-6.7

found in adults (Telofski et al, 2012).

The acid mantel has multiple effects

on the skin, including a role in normal

skin shedding (desquamation), and

maintenance of the permeability

barrier and the integrity of the stratum

corneum (Cork et al, 2006). Skin pH

is also important because of its role in

promoting the skin’s microbiome, the

diverse harmless or beneficial micro-

organisms that colonise the human

skin surface (Grice and Segre, 2011).

The microbiome is gradually acquired

from birth, and is thought to be critical

for the effectiveness of the skin’s

immune response against disease-

causing bacteria, and possibly for the

development of a healthy skin barrier

and systemic immune system (Capone

et al, 2010).

Infant skin differs from adult skin in its

structure, function and composition,

and needs appropriate, evidence-based

care to maintain the integrity of the skin

barrier (Telofski et al, 2012). At the same

FAST FACTS (KOTTNER ET AL, 2013)

• Transepidermal water loss (TEWL) is the measurement of the amount of water diffused through the hydrated inner layers of the dermis and epidermis to the skin surface

• TEWL is regarded as one of the most important parameters for skin barrier function

• A high TEWL level suggests that skin barrier function is impaired

• A normal or reduced TEWL indicates that the skin barrier is intact or has recovered

Understanding newborn skin

More high-quality evidence, together

with greater recognition of latest clinical

data in infant skin care, is essential to

resolve uncertainty among midwives and

confusion among women. Evidence from

well-conducted randomised controlled

trials has recently become available, but

any approach to newborn skin care must

also depend on an understanding of the

structure and physiology of newborn

skin.

FAST FACTS

• There is a lack of expert consensus concerning newborn cleansing

• This lack of consensus has led to uncertainty among midwives and confusion among parents

• Randomised controlled trials provide the best evidence for the effectiveness and safety of a treatment

• Recently published randomised controlled trials may influence updated NICE guidelines on routine newborn cleansing

5

time, cleansing must effectively remove

unwanted substances from the skin to

maintain good health and hygiene in

infants (Telofski et al, 2012).

FAST FACTS (TELOFSKI ET AL, 2012)

• Full-term babies are born with a functioning skin barrier that continues to mature during the first year of life

• Infant skin differs from adult skin in its structure, composition and functions

• In newborns, the skin barrier is thinner than in adults, is more acidic and more easily loses water

• Infant skin needs special care to ensure that the health of the skin barrier is maintained

The importance of effective skin cleansing In infants, effective cleansing is essential

to remove substances such as milk, food,

nasal secretions and saliva that may

potentially cause irritation if left on the

skin (Stamatas et al, 2011). The infant’s

overall health also depends on keeping

the skin free of harmful bacteria in urine

and faeces that cause irritation and

may lead to infection if transferred to

the baby’s mouth (Stamatas et al, 2011;

Telofski et al 2012).

The techniques and agents used

to cleanse the skin have a role in

maintaining and restoring the skin

barrier (Fowler et al, 2013). Cleansing

may, however, have negative effects on

the stratum corneum depending on the

methods chosen (Fowler et al, 2013).

JUST SOAP AND WATER?

Soap is an effective cleanser, but it

also causes skin dryness and irritation

(Telofski et al, 2012). These negative

effects are likely to be due to the effects

of soap on skin lipids (fats) and pH,

which in turn impair the integrity of the

skin barrier (Ananthapadmanabhan et al,

2004).

The lipids surrounding the cells of the

stratum corneum play an essential role

in preventing loss of water and essential

blood minerals (electrolytes) through the

skin barrier (Feingold 2007). Although

any method of washing removes lipids

from the outer layers of the skin, loss of

lipids after washing with soap is greater

than after using either water or mild,

synthetic detergents (‘syndets’) (Blume-

Peytavi et al, 2012). The lipid content of

the skin is gradually restored over time,

but it is not recovered two hours after

washing with soap and such changes

in the lipid composition of the stratum

corneum may reduce skin barrier

function (Blume-Peytavi et al, 2012).

Soaps are typically alkaline, and have

been shown to increase the pH of infant

skin and disturb the acid mantel for

up to 30 minutes (Blume-Peytavi et al,

2012). Infant skin takes longer than adult

skin to restore the acid mantel (Blume-

Peytavi et al, 2012) and sustained pH

increases, such as those caused by

soap-based cleansers, have been shown

to adversely affect barrier function in

normal skin (Ali and Yosipovitich, 2013).

There is a correlation between high

TEWL and damage to the surface

structure of the stratum corneum

seen after washing with alkaline soap

(Ananthapadmanabhan et al, 2004). In

contrast, ‘syndets’ that are specifically

formulated for use in infants minimally

alter skin pH and deplete skin lipids, are

associated with a lower rate of TEWL

and are more able to maintain the

barrier function of the skin (Stamatas et

al, 2011).

Although water alone is recommended

for cleansing newborn skin, it is not an

effective cleanser because it cannot

dissolve faeces and other greasy

substances (Gelmetti 2001). Since these

substances are fat-soluble, they are

held on the skin by surface tension and

can only be removed by surfactants

(‘surface-acting’ agents) that break them

down into fine droplets that can then be

easily rinsed away with water (Gelmetti

2001).

Water is also a skin irritant, causing

itching and dryness (Tsai and Maibach

1999). It is rapidly absorbed into

the skin, especially through the still-

developing infant stratum corneum. This

hydrates the skin, but the effect is only

temporary since the added water quickly

evaporates through TEWL, leaving the

skin dryer than before (Ewence et al,

2011). When it penetrates the skin, water

may also increase the spaces between

the corneocytes of the stratum corneum,

impairing the integrity of the skin barrier

and allowing pathogens and allergens

through the skin (Ewence et al, 2011).

It is important to remember that tap

water does not just consist of H20—i.e.

two hydrogen atoms for every one

oxygen atom. It also contains dissolved

minerals such as calcium or magnesium

that determine whether the water is hard

or soft (Ewence et al, 2011). This in turn

influences the pH of water—i.e. whether

6

it is acid, alkaline or neutral—but both

hard and soft tap water is relatively more

alkaline than the acid surface pH of the

skin (Ewence et al, 2011, Telofski et al

2012).

Rinsing with even slightly alkaline tap

water can raise skin pH for several hours,

reducing the function of the acid mantel

and promoting breakdown of the skin

barrier (Ewence et al, 2011). Since the

skin is the body’s first line of defence

against harmful irritants and allergens,

impairment of the delicate newborn

skin barrier has been identified as an

important factor in placing susceptible

infants at risk of skin problems such as

atopic dermatitis (AD), also known as

atopic eczema (Cork et al, 2006).

ATOPIC DERMATITISAtopic dermatitis (AD) is an extremely

common, chronic inflammatory skin

condition that usually starts during the

first months of life (British Association

of Dermatologists 2013). The causes

are complex, but AD is thought to be

the result of an interaction between

inherited predisposition and breakdown

of the skin barrier due to adverse

environmental effects (Cork et al, 2006).

Several factors are associated with the

development of AD, but increasing use

of soap and detergents, especially with

hard water, has been cited as one of the

most important because of their effects

on the stratum corneum (Cork et al,

2009).

The stratum corneum is like a brick wall

in which the bricks (the corneocytes) are

surrounded by mortar (the lipid lamellae)

and are supported by iron rods (proteins

called corneodesmosomes). When an

infant is genetically predisposed to AD,

the corneodesmosomes break down

prematurely below the skin surface

(Cork et al, 2006). In infants with AD, the

stratum corneum resembles a brick wall

in which the supportive iron rods have

rusted, leaving it more vulnerable to

the effects of the external environment.

When the stratum corneum is impaired—

for example, through the effects of

soap on skin lipids and pH—the skin

barrier can no longer prevent allergens

and infection from reaching the

dermis, leading to the inflammation

characteristic of AD (Cork et al, 2006).

Conversely, preservation or restoration

of a functional skin barrier may reduce

the risk or possibly the severity of AD

(Stamatas et al, 2011). As a result,

appropriate care of newborn skin may

have significant long-term implications

for health (Bedwell and Lavender 2012)

and this highlights the need for suitable

skin care regimens (Lavender et al, 2013).

FAST FACTS (EWENCE ET AL, 2011, TELOFSKI ET AL, 2012) • Pure (distilled) water has a neutral

pH of 7.0

• Naturally soft tap water generally has a pH of 8.0-8.5

• The pH of naturally hard water is generally maintained at about 7.5

• Full-term newborn skin has a neutral pH of 6.34-7.5 at birth, falling to a more acidic pH of 5.0 in

the first two weeks of life

FAST FACTS (BLUME-PEYTAVI ET AL, 2012; CORK ET AL, 2006; EWENCE ET AL, 2011; STAMATAS ET AL, 2011) • Soap is an effective cleanser, but

increases transepidermal water loss and causes skin dryness and irritation

• Water alone is not an effective skin cleanser and may also cause dryness and itching

• Impairment to the skin barrier may contribute to the development of atopic dermatitis in susceptible infants

• Mild, optimally formulated wash products that do not alter skin pH, cleanse infant skin effectively and maintain the skin barrier

pH Scale

NeutralIncreasing Acidity

• The pH scale ranges from 0 to 14 and measures the acidity or alkalinity of a substance • Pure (distilled) water has a neutral pH of 7• A pH of less than 7 is acidic, and pH greater than 7 is alkaline

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14

Increasing Alkalinity

1a 1b

1a & 1b source: CORK ET AL, 2006

7

Until recently, there were no robust

clinical studies investigating the routine

cleansing of newborn skin. Small-scale

studies have in the past indicated that

specially formulated products are as well

tolerated as water alone when used to

cleanse newborns. It has, however, been

challenging to draw overall conclusions

because of differences in the studies’

participants, methods and outcome

measures.

A trial including 180 healthy infants

(aged from one day to one year) found

no significant differences between

a wash product and water alone in

outcomes such as swelling, redness and

irritation, dryness or scaling (Dizon et al,

2010). A second study randomised 64

healthy, full-term newborns (aged less

than 48 hours) to four groups: twice-

weekly bathing with wash gel, or cream,

or wash gel and cream, or water alone.

At the end of eight weeks, there was

significantly less TEWL at all studied

body sites in babies randomised to wash

gel and cream or cream alone compared

to those assigned to water alone (Garcia

Bartels, et al 2010).

Skin pH was significantly lower in

the wash gel group than in babies

randomised to water, an effect that

persisted until the eighth week of life

(Garcia Bartels et al, 2010). A higher skin

surface pH has been related to higher

rates of bacterial proliferation

and greater activity of proteolytic

enzymes that are detrimental to skin

barrier function (Blume-Peytavi et al,

2012). This has potentially important

implications for future skin health,

since studies have found that skin pH

is significantly raised in patients with

AD compared to that of controls with

healthy skin. This higher skin pH is seen

even in unaffected skin of patients

with AD, and can be expected to delay

recovery and facilitate breakdown of the

skin barrier (Cork et al, 2009),

LATEST EVIDENCEIn 2009 a European Round Table

consensus on newborn cleansing called

for further clinical research to investigate

the potential benefits of appropriate

cleansers (Blume-Peytavi et al, 2009).

This research is now available in two

large, investigator-led, randomised

controlled trials that confirm the

tolerability of some specially formulated

and robustly tested, mild and gentle

cleansers (Lavender et al, 2012; Lavender

et al, 2013).

Both trials were conducted by a

multidisciplinary team at Central

Manchester NHS Foundation Trust.

These studies compared the safety

of JOHNSON’S® Baby Top-to-Toe®

Bath and JOHNSON’S® Baby Extra

Sensitive Wipes on healthy newborn

skin, against water alone. The two trials

were funded by an educational grant

from Johnson & Johnson, who agreed

that the researchers would publish the

results of their studies regardless of

outcomes. Both trials were independently

designed and led by the researchers; this

included the trial design, data analysis,

interpretation of results and production

of the manuscript.

Given the lack of previous large, robust

randomised controlled trials, the design

of both studies was based on the

findings of a pilot randomised controlled

trial that included 100 healthy newborns

(Lavender et al, 2011). The results of

this study were used to determine the

number of participants needed to obtain

statistically significant results in the

larger trials and the validity of TEWL

as an outcome in newborns.

Babies and mothers participating in

both trials were recruited within 48

hours of birth. To avoid biasing the

results of either study, the babies were

randomly assigned to their treatment.

This was done through either computer-

generated telephone randomisation

(Lavender et al, 2012) or consecutively

numbered, sealed, opaque envelopes

held by the research manager at the

study hospital (Lavender et al, 2013).

In both randomised trials, the study

groups were similar in terms of maternal

characteristics, the babies’ gender,

feeding method and birth weight, and

the method of birth.

The aim of both studies was to

demonstrate that the products under

investigation had an equivalent effect—

i.e. were ‘non-inferior’—to usual care

with water and cotton wool. Outcomes

of the two studies were assessed by

research midwives who were unaware

of the babies’ allocated treatment. The

mothers also completed questionnaires

and diaries. It was not possible to ‘blind’

the mothers to their babies’ allocation

because of obvious differences between

the treatments under investigation.

WATER VERSUS WASH PRODUCT (Lavender et al, 2013)

The first trial included 307 newborns

randomised to either bathing with a

wash product or water alone. The wash

product was non-inferior to water

alone on the primary study outcome of

TEWL at 14 days. There were also no

significant differences on secondary

outcomes, including changes in stratum

corneum hydration, skin surface pH, and

clinically observed dryness, redness or

excoriation.

The mothers’ overall satisfaction

was similar in the two groups, but

there were some difference in their

perceptions of their assigned treatments.

Mothers using the wash product were

significantly more likely than those

using water to report that their newborn

smelled good (p<0.001). Mothers in this

group who continued using the wash

product were also significantly more

likely to maintain the same bathing

regimen after the end of the study

(p=0.010 versus water alone).

WATER VERSUS BABY WIPES (Lavender et al, 2012)

For the second study, researchers

recruited 280 newborns, who were

randomly assigned to have their nappy

area cleansed with a fragrance-free

baby wipe or cotton wool and water.

The wipes were equivalent to water and

New evidence on infant cleansing

FAST FACTS (LAVENDER ET AL, 2012; LAVENDER ET AL, 2013) • New evidence is now available from

the two largest-ever randomised controlled trials on skin cleansing in healthy newborns

• A trial including 307 babies shows that a certain mild and gentle, pH-neutral, specifically formulated and robustly tested cleanser can be used safely on newborn skin

• A trial in 280 babies shows that a certain wipe impregnated with pH-neutral lotion is appropriately designed for use on infant skin and has been clinically tested and proven safe even for newborns

• The results of these two clinical trials cannot be extrapolated to demonstrate the efficacy and safety of other infant cleansing products

8

When caring for newborn skin, it

is essential to balance the need for

effective cleansing with the preservation

of the skin barrier. NICE guidance is

a benchmark for advising healthcare

professionals on best practice, yet in

the case of infant skincare the current

guideline is informed by anecdotal

expert thinking and is now outdated

due to recent evidence provided by the

clinical trials discussed.

Randomised controlled trials are

essential to provide high-level evidence

to support midwives when parents seek

advice about cleansing their newborn.

The two recently published studies

discussed in this supplement are the

largest randomised controlled trials to

date to investigate cleansing practices in

healthy newborns—specifically the role

of a wash product and wipes specifically

formulated for newborn cleansing.

Since randomised controlled trials are

widely accepted as the highest level of

evidence, the results of these studies

may influence future recommendations

from guideline developers such as NICE.

Such guidelines on newborn skin care

should also take into account research

on the adverse effects of soap on the

development of the skin barrier, and

draw on the results of randomised

controlled trials to provide specific

recommendations on the choice of

specially formulated, pH-balanced,

soap-free products.

Good practice guidelines are needed to

enable midwives to provide guidance

and support to parents, who will

ultimately choose on how best to

care for their baby’s skin based on

their personal preferences and beliefs

(Steen and Macdonald 2008). The

latest AWHONN guidelines provide

helpful advice for midwives to pass on

to parents who choose to use baby

cleansers rather than water alone to care

for their baby’s skin.

The two randomised clinical trials

investigating the role of a specially

formulated wash product and wipes

in the care of newborn skin provide

important evidence and some

reassurance for both professionals and

parents, but their results cannot be

generalised beyond the products tested.

Since the publication of the latest NICE

guideline in 2006, expert debate and

research into effective infant cleansing

has progressed. Achieving the goal

of a truly evidence-based approach

to newborn skin cleansing depends

on greater recognition of the latest

clinical data and further high-quality

randomised controlled trials to support

professional advice and help to promote

informed choice for parents.

Conclusions

Akobeng AK. (2005) Understanding randomised controlled trials. Arch Dis Child 90: 840-44

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cotton wool on the primary outcome of

change in skin hydration from within 48

hours to four weeks after birth. There

were also no significant differences

on the secondary clinical outcomes

of changes in TEWL, skin surface pH,

erythema, and the presence of microbial

skin contaminants or irritants at four weeks.

The assessing midwives reported

similar rates of nappy dermatitis at four

weeks in the two treatment groups.

However, mothers in the wipes group

were significantly less likely to report

nappy dermatitis than those in the water

group (p = 0.025). According to the

researchers, although more credence

might initially be given to the midwives’

assessment, mothers could be seen as

the experts in their babies’ skin in this

study. This was because the mothers

assessed their babies’ skin every day,

whereas the midwives examined

the babies twice during the study at

intervals of four weeks.

EVIDENCE INTO PRACTICEThe findings of these two largest-

ever randomised trials to investigate

cleansing practices in newborns provide

important evidence to support midwives

when asked for advice on newborn

cleansing. The results should also be

reassuring to parents who choose to use

specifically formulated products to care

for their babies’ skin. However, since the

findings of these two studies relate to

the products tested, it is risky to assume

that results would necessarily be the

same for other baby products currently

available to parents.