Bag and mattress or bag for preterm infants in the delivery room: The Bambino Trial

ISRCTN	ISRCTN31707342
DOI	https://doi.org/10.1186/ISRCTN31707342
Protocol serial number	N/A
Sponsor	The National Children's Research Centre (Ireland)
Funder	The National Children's Research Centre (Ireland)

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

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

Email	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	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(s)	Core temperature 36.5 - 37.5°C on admission to the Neonatal Intensive Care Unit (NICU)
Key secondary outcome measure(s)	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
Completion date	30/06/2012

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	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

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	01/07/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes