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

• Register: ISRCTN
• Last refreshed on: 12 February 2013
• Main ID: ISRCTN31707342
• Date of registration: 03/03/2011
• Primary sponsor: The National Children's Research Centre (Ireland)
• Public title: Bag and mattress or bag for preterm infants in the delivery room: The Bambino Trial 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
• Date of first enrolment: Jan 11 2011
• Target sample size: 116
• Recruitment status: Completed/Not recruiting
• URL: http://isrctn.org/ISRCTN31707342
• Study type: Interventional
• Study design: Randomised controlled trial

Countries of recruitment

Ireland

Contacts

• Name: Colm O'Donnell

Key inclusion & exclusion criteria

Inclusion criteria: Infants born at the National Maternity Hospital (NMH) at less than 31 weeks gestation by best obstetric estimate
Exclusion criteria: Known congenital anomaly with an open lesion (e.g. gastroschisis or myelomeningocele)

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Prematurity/prevention of hypothermia in newborns

Intervention(s)

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(s)

Core temperature 36.5 - 37.5°C on admission to the Neonatal Intensive Care Unit (NICU)

Secondary Outcome(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

Secondary ID(s)

N/A

Source(s) of Monetary Support

The National Children's Research Centre (Ireland)

Secondary Sponsor(s)

N/A