Placing preterm infants on their back or in recovery position on their left side at birth

ISRCTN ISRCTN74486341
DOI https://doi.org/10.1186/ISRCTN74486341
Secondary identifying numbers BREL001
Submission date
19/09/2012
Registration date
16/10/2012
Last edited
08/02/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Premature babies are routinely placed flat on their backs after birth. Though the majority of them breathe spontaneously, they often have difficulty breathing and are given support in the delivery room. Obstruction of the airway of premature babies during breathing support in the delivery room is common. Spontaneously breathing premature infants are often placed on their side or on their front in the nursery as they appear to breathe better in these positions than if they are placed on their back. Older children and adults with reduced consciousness who breathe spontaneously are placed on their side in the recovery position to keep their airway open. We aim to determine whether premature babies breathe more effectively, demonstrated by having higher oxygen saturation (SpO2), at 5 minutes of life if they are placed on their side rather than on their back.

Who can participate?
Babies born at < 32 weeks’ gestation who do not have major congenital anomalies will be enrolled.

What does the study involve?
They will be randomly assigned to be placed on their back or on their left side just before birth and placed in their assigned position when they arrive on the resuscitation table; their care will be identical in all other respects. They will have a pulse oximeter that will measure their SpO2 placed on their right wrist shortly after birth. The SpO2 at 5 minutes of life of all babies in both groups will recorded and compared.

What are the possible benefits and risks of participating?
It is possible that babies in one group may breathe more effectively than the other, though this will not be known until all babies have been enrolled and the data has been analysed. We know of no additional risks above those associated with prematurity that babies will encounter by participating in this study.

Where is the study run from?
The National Maternity Hospital, Holles Street, Dublin, Ireland.

When is study starting and how long is it expected to run for?
It will start in October 2012 and should be completed in 9 months.

Who is funding the study?
The study is supported by The National Children’s Research Centre, Dublin, Ireland.

Who is the main contact?
Dr Colm O’Donnell
codonnell@nmh.ie

Contact information

Dr Colm O'Donnell
Scientific

Neonatal Intensive Care Unit
The National Maternity Hospital
Holles Street
Dublin
2
Ireland

Phone +353 (0)16 373 100
Email codonnell@nmh.ie

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised trial of placing preterm infants on their back or in recovery position on their left side at birth
Study acronymBREL
Study objectivesPreterm infants breathe more effectively after birth if they are placed on their left side than if they are placed on their backs.
Ethics approval(s)The National Maternity Hospital Research Ethics Committee, Dublin, Ireland, 17/09/2012
Health condition(s) or problem(s) studiedPrematurity, respiratory distress syndrome
InterventionPlacement in the recovery position on the left side or on their back
Intervention typeOther
Primary outcome measureOxygen saturation (SpO2) measured pre-ductally (i.e. from the right upper limb) at 5 minutes of life
Secondary outcome measures1. Heart rate (HR) at 5 minutes
2. SpO2 at 10 minutes
3. HR at 10 minutes
4. Apgar score at 1 minute
5. Apgar score at 5 minutes
6. Apgar score at 10 minutes
7. Time to SpO2 > 90%
8. HR < 100 in the DR
9. Duration of HR < 100 in the DR
10. Use of CPAP in the DR
11. Use of PPV in the DR
12. Use of > 30% oxygen in the DR
13. Maximum FiO2 in the DR
14. Intubation in the DR
15. Chest compressions in the DR
16. Volume resuscitation in the DR
17. Intubation during hospitalisation
18.Surfactant use
19. Duration of ventilation (hours)
20. Duration of CPAP (days)
21. Postnatal corticosteroid use
22. Bronchopulmonary dysplasia ¨C oxygen therapy at 28 days of life
23. Chronic lung disease oxygen therapy at 36 week's postmenstrual age
24. Cranial ultrasound abnormalities (intraventricular haemorrhage, cystic PVL, ventricular dilatation)
25. Medical treatment for PDA
26. PDA ligation
27. NEC Bells stage 2
28. Retinopathy of prematurity
29. Duration of hospital stay
30. Death before discharge from hospital
Overall study start date19/10/2012
Completion date30/06/2013

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants82
Key inclusion criteriaInfants born at the NMH at < 32 weeks gestation (i.e. up to 31+6 weeks)
Key exclusion criteriaInfants with a major congenital anomaly, for example:
1. Diaphragmatic hernia
2. Cardiac anomaly other than patent ductus arteriosus
3. Ventricular septal defect or atrial septal defect
4. Gastroschisis
5. Omphalocoele
6. Oesophageal atresia with tracheo-oesophageal fistula Pierre-Robin sequence
Date of first enrolment19/10/2012
Date of final enrolment30/06/2013

Locations

Countries of recruitment

  • Ireland

Study participating centre

The National Maternity Hospital
Dublin
2
Ireland

Sponsor information

The National Maternity Hospital (Ireland)
Hospital/treatment centre

c/o Dr Colm O'Donnell
Neonatal Intensive Care Unit
Dublin
2
Ireland

Website http://www.nmh.ie/
ROR logo "ROR" https://ror.org/03jcxa214

Funders

Funder type

Hospital/treatment centre

National Children’s Research Centre (Ireland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2016 Yes No

Editorial Notes

08/02/2016: Publication reference added.