Bag and mattress or bag for preterm infants in the delivery room: The Bambino Trial
| ISRCTN | ISRCTN31707342 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31707342 |
| Secondary identifying numbers | N/A |
- Submission date
- 31/01/2011
- Registration date
- 03/03/2011
- Last edited
- 04/09/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Colm O'Donnell
Scientific
Scientific
Neonatal Intensive Care Unit
The National Maternity Hospital
Holles Street
Dublin
2
Ireland
| codonnell@nmh.ie |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Should exothermic mattresses be used in combination with polyethylene bags to prevent heat loss in preterm infants at birth? (bag and mattress or bag in the delivery room): a randomised controlled trial |
| Study acronym | The Bambino Trial |
| Study objectives | For newborn infants less than 31 weeks nursed in polyethylene bags under radiant heat, the use of exothermic mattresses results in more infants with admission temperatures outside the normal range (core temperature 36.5 - 37.5°C). |
| Ethics approval(s) | Ethics Committee of The National Maternity Hospital, Dublin, approved on the 22nd December 2010 |
| Health condition(s) or problem(s) studied | Prematurity/prevention of hypothermia in newborns |
| Intervention | Infants in both groups will be placed in a polyethylene bag and placed under radiant heat after birth. Infants randomised to the "bag" group will receive no additional measures to provide heat. Infants randomised to "mattress group" will, in addition, be placed on an exothermic chemical mattress (TransWarmer® Infant Transport Mattress, Cooper Surgical Inc., Trumbull CT, USA) which will be activated before delivery. The primary outcome for this trial is the infant's core (rectal) temperature on admission to the neonatal intensive care unit. All infants will be followed until hospital discharge. |
| Intervention type | Other |
| Primary outcome measure | Core temperature 36.5 - 37.5°C on admission to the Neonatal Intensive Care Unit (NICU) |
| Secondary outcome measures | 1. Apgar scores at 5 and 10 minutes 2. Positive pressure ventilation (PPV) in the delivery room (DR) 3. Intubation and mechanical ventilation in the DR 4. Supplemental oxygen in the DR 5. Chest compressions in the DR 6. Use of adrenaline and volume resuscitation in the DR 7. Time to NICU admission 8. Intubation and mechanical ventilation during hospital stay 9. Duration of oxygen therapy (hours and days) 10. Oxygen therapy at 28 days 11. Oxygen therapy at 36 weeks' corrected gestational age 12. Sepsis early and late onset 13. Patent ductus arteriosus 14. Intraventricular haemorrhage 15. Periventricular leukomalacia 16. Necrotising Enterocolitis 17. Hospital days 18. Death before hospital discharge |
| Overall study start date | 11/01/2011 |
| Completion date | 30/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 116 |
| Key inclusion criteria | Infants born at the National Maternity Hospital (NMH) at less than 31 weeks gestation by best obstetric estimate |
| Key exclusion criteria | Known congenital anomaly with an open lesion (e.g. gastroschisis or myelomeningocele) |
| Date of first enrolment | 11/01/2011 |
| Date of final enrolment | 30/06/2012 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Neonatal Intensive Care Unit
Dublin
2
Ireland
2
Ireland
Sponsor information
The National Children's Research Centre (Ireland)
Research organisation
Research organisation
Our Lady's Children's Hospital
Crumlin
Dublin
12
Ireland
| Website | http://www.nmh.ie/iopen24/index.php |
|---|---|
"ROR" |
https://ror.org/025qedy81 |
Funders
Funder type
Research organisation
The National Children's Research Centre (Ireland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 01/07/2013 | Yes | No |
