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Bag and mattress or bag for preterm infants in the delivery room: The Bambino Trial
ISRCTN ISRCTN31707342
DOI 10.1186/ISRCTN31707342
ClinicalTrials.gov identifier
EudraCT number
Public title Bag and mattress or bag for preterm infants in the delivery room: The Bambino Trial
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
Acronym The Bambino Trial
Serial number at source N/A
Study hypothesis 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).
Lay summary Not provided at time of registration
Ethics approval Ethics Committee of The National Maternity Hospital, Dublin, approved on the 22nd December 2010
Study design Randomised controlled trial
Countries of recruitment Ireland
Disease/condition/study domain Prematurity/prevention of hypothermia in newborns
Participants - inclusion criteria Infants born at the National Maternity Hospital (NMH) at less than 31 weeks gestation by best obstetric estimate
Participants - exclusion criteria Known congenital anomaly with an open lesion (e.g. gastroschisis or myelomeningocele)
Anticipated start date 11/01/2011
Anticipated end date 30/06/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 116
Interventions 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.
Primary outcome measure(s) Core temperature 36.5 - 37.5°C on admission to the Neonatal Intensive Care Unit (NICU)
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
Sources of funding The National Children's Research Centre (Ireland)
Trial website
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23776115
Contact name Dr  Colm  O'Donnell
  Address Neonatal Intensive Care Unit
The National Maternity Hospital
Holles Street
  City/town Dublin
  Zip/Postcode 2
  Country Ireland
  Email codonnell@nmh.ie
Sponsor The National Children's Research Centre (Ireland)
  Address Our Lady's Children's Hospital
Crumlin
  City/town Dublin
  Zip/Postcode 12
  Country Ireland
  Sponsor website: http://www.nmh.ie/iopen24/index.php
Date applied 31/01/2011
Last edited 04/09/2013
Date ISRCTN assigned 03/03/2011
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