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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN31707342

Enrollment

116

Registered

2011-03-03

Start date

2011-01-11

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity/prevention of hypothermia in newborns Pregnancy and Childbirth Prematurity

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. Infant

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Infants born at the National Maternity Hospital (NMH) at less than 31 weeks gestation by best obstetric estimate

Exclusion criteria

Exclusion criteria: Known congenital anomaly with an open lesion (e.g. gastroschisis or myelomeningocele)

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 16, 2026