Condition category
Neonatal Diseases
Date applied
19/09/2012
Date assigned
16/10/2012
Last edited
08/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Colm O'Donnell

ORCID ID

Contact details

Neonatal Intensive Care Unit
The National Maternity Hospital
Holles Street
Dublin
2
Ireland
+353 (0)16 373 100
codonnell@nmh.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BREL001

Study information

Scientific title

A randomised trial of placing preterm infants on their back or in recovery position on their left side at birth

Acronym

BREL

Study hypothesis

Preterm infants breathe more effectively after birth if they are placed on their left side than if they are placed on their backs.

Ethics approval

The National Maternity Hospital Research Ethics Committee, Dublin, Ireland, 17/09/2012

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Prematurity, respiratory distress syndrome

Intervention

Placement in the recovery position on the left side or on their back

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Oxygen saturation (SpO2) measured pre-ductally (i.e. from the right upper limb) at 5 minutes of life

Secondary outcome measures

1. 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 trial start date

19/10/2012

Overall trial end date

30/06/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Infants born at the NMH at < 32 weeks gestation (i.e. up to 31+6 weeks)

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

82

Participant exclusion criteria

Infants 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

Recruitment start date

19/10/2012

Recruitment end date

30/06/2013

Locations

Countries of recruitment

Ireland

Trial participating centre

The National Maternity Hospital
Dublin
2
Ireland

Sponsor information

Organisation

The National Maternity Hospital (Ireland)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.nmh.ie/

Funders

Funder type

Hospital/treatment centre

Funder name

National Children’s Research Centre (Ireland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26847368

Publication citations

Additional files

Editorial Notes

08/02/2016: Publication reference added.