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Page1 Date: 16/06/2021
RANDOMISE – Have the following info at hand
Date and time of birth
Gestation in weeks and days
Birthweight
Details of any previous surfactant administration
Current mode of respiratory support 3. Go to computer 4. Paanui/Kidz First/neonatal clinical guidelines/research studies
Alternative: (via Firefox https://redcap.mcri.edu.au) 5. Username and password. User: pluss.middlemore Password: MMNZ04pluss 6. Go to ‘New Randomisation’ then select randomise 7. Type in your name and the study email address: PLUSS@auckland.ac.nz 8. Complete fields for eligibility 9. You will be taken to a new window to check details and confirm. At the completion of the randomisation process, print out
the randomisation form which has the PLUSS study envelope number and the appropriate doses of Curosurf and Budesonide for weight (note budesonide dose is provided for all babies regardless of allocation arm).
HOW TO RANDOMISE AND PERFORM INTERVENTION
INFORMED WRITTEN CONSENT obtained
Parent Information and consent form in box on PLUSS trolley
1. Signed consent (leave at bedside table) 2. Sign PLUSS consent label and place in medical notes
ASSEMBLE PLUSS INTERVENTION TEAM
Two people not directly involved in the care of the patient, e.g., resource nurse, ACCN, RN, MW, CNS or SMO/RMO
Collect surfactant from drug fridge (budesonide is on the PLUSS trolley)
Take PLUSS trolley to an area out of view of the clinical team to maintain blinding
Meets All Inclusion criteria
• less than 28 weeks’ gestation AND Less than 48 hours of age
• If previous surfactant, 6‐12 hours post first dose
• Receiving mechanical ventilation via an endotracheal tube OR receiving non‐invasive respiratory support (CPAP, NIPPV or nasal
high flow) and a clinical decision to treat with exogenous surfactant
No Exclusions
• Prior treatment with corticosteroids for the prevention of lung disease (inhaled, nebulised, intra‐tracheal, or systemic)
• Infant is considered non‐viable or is not going to be admitted to intensive care
• Known or suspected major congenital anomaly that is likely to affect respiratory status
• Infant likely to be transferred to another non‐participating NICU within 24 hours of birth
PRESCRIBE INTERVENTION
Consultant/Fellow/CNS to prescribe study #1 intervention on medication chart as a stat order (see example below)
Page2 Date: 16/06/2021
PREPARE INTERVENTION
1. Find the following in the red box on the PLUSS trolley
a. PLUSS study envelope – match to the assigned randomisation number
b. PLUSS enrolment pack – red plastic sleeve (syringe labels, cot cards, data collection forms)
2. Open brown study envelope to find two further envelopes: BLUE for 1st intervention and GREEN for optional 2nd
intervention (keep green 2nd envelope at bedside & only open if required; otherwise return to red lock box if not used).
3. Open the BLUE allocation envelope to reveal the allocated treatment on the allocation card
a. Curosurf and budesonide
b. Curosurf only (NO budesonide)
4. Draw up study medications as below (calculations are printed on REDCap randomisation form):
Draw up Curosurf® using a 5 ml syringe and a yellow 20 g needle and pull back plunger to create air bolus (note – Curosurf is drawn up to one decimal place) 1st study intervention = 200 mg/kg (2.5 ml/kg) (regardless if had previous surfactant) 2nd study intervention = 100 mg/kg (1.25 ml/kg)
If allocated to budesonide, draw up 0.25 mg/kg (0.5 ml/kg) in a 1 ml syringe with blunt needle (note budesonide is drawn up to two decimal places); add budesonide to the Curosurf® syringe
5. Cap the syringe and gently invert several times to mix.
6. Cover syringe with PLUSS labels to conceal volume and appearance.
7. Complete fields on the allocation card, fold in half and post in the red metal lock box.
8. Dispose of used medicine vials immediately into sharps container.
PLUSS ‐ BEDSIDE PROCEDURE
1. Commence blood collection schedule (if baby has an arterial line)
2. Commence blue 1st intervention data collection form
3. One person from the intervention team assists in administering the surfactant and signs the drug chart. The other member
of the intervention team signs for checking the surfactant dose.
4. Surfactant given as per local protocol
5. Complete blue 1st intervention data collection form and put in the draw of the bedside table.
6. Place PLUSS cot card at front of cot so staff aware that baby is part of PLUSS study.
REASSESS IN 6‐12 HOURS for optional 2nd intervention The 2nd intervention is indicated if still ventilated via an endotracheal tube OR on non‐invasive respiratory support with a clinical decision to repeat surfactant treatment There are a maximum of 2 trial interventions (in addition to previous surfactant)
2nd intervention Repeat steps above Use GREEN allocation envelope, green intervention data form
Page3 Date: 16/06/2021
Example Prescription on national medication chart
Page4 Date: 16/06/2021
PLUSS Study envelope
Blue #1 allocation envelope and allocation card (Curosurf only example)
This allocation card is returned to the red metal lock box once completed. Do not leave at the
bedside. Ensure that no one other than the intervention team sees this card.
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