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 |
| Protocol serial number | BREL001 |
| Sponsor | The National Maternity Hospital (Ireland) |
| Funder | National Childrens Research Centre (Ireland) |
- 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
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 Childrens Research Centre, Dublin, Ireland.
Who is the main contact?
Dr Colm ODonnell
codonnell@nmh.ie
Contact information
Scientific
Neonatal Intensive Care Unit
The National Maternity Hospital
Holles Street
Dublin
2
Ireland
| Phone | +353 (0)16 373 100 |
|---|---|
| codonnell@nmh.ie |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised trial of placing preterm infants on their back or in recovery position on their left side at birth |
| Study acronym | BREL |
| Study objectives | 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(s) | The National Maternity Hospital Research Ethics Committee, Dublin, Ireland, 17/09/2012 |
| Health condition(s) or problem(s) studied | Prematurity, respiratory distress syndrome |
| Intervention | Placement in the recovery position on the left side or on their back |
| Intervention type | Other |
| Primary outcome measure(s) |
Oxygen saturation (SpO2) measured pre-ductally (i.e. from the right upper limb) at 5 minutes of life |
| Key secondary outcome measure(s) |
1. Heart rate (HR) at 5 minutes |
| Completion date | 30/06/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 82 |
| Key inclusion criteria | Infants born at the NMH at < 32 weeks gestation (i.e. up to 31+6 weeks) |
| Key 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 |
| Date of first enrolment | 19/10/2012 |
| Date of final enrolment | 30/06/2013 |
Locations
Countries of recruitment
- Ireland
Study participating centre
2
Ireland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
08/02/2016: Publication reference added.
