Respiratory support for preterm infants in the delivery room: Single nasal prong or face mask?

Respiratory support for preterm infants in the delivery room: Single nasal prong or face mask? A randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN59061709

Enrollment

142

Registered

2010-10-25

Start date

2010-07-19

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

Respiratory support of preterm infants at birth Neonatal Diseases

Interventions

Respiratory support with a T-piece device using a single nasal prong (AKA short nasal tube AKA nasopharyngeal tube) compared to respiratory support with a T-piece device using a face mask.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Infants born at The National Maternity Hospital at < 31 weeks gestation who receive respiratory support at birth

Exclusion criteria

Exclusion criteria: Infants with congenital anomalies

Design outcomes

Primary

Measure	Time frame
Intubation and mechanical ventilation in the delivery room	—

Secondary

Measure	Time frame
1. Heart rate at five minutes 2. Use of supplemental oxygen in the DR 3. Chest compressions in the DR 4. Use of adrenaline and volume resuscitation in the delivery room 5. Apgar scores at 5 and 10 minutes 6. Temperature on arrival to NICU 7. Air leak (pneumothorax, pneumopericardium) 8. Intubation and mechanical ventilation =72 hours of life 9. Intubation and mechanical ventilation during hospital stay 10. Surfactant use 11. Duration of mechanical ventilation (hours & days) 12. Duration of CPAP (hours & days) 13. Duration of oxygen therapy (hours & days) 14. Oxygen therapy at 28 days 15. Oxygen therapy at 36 weeks? post-menstrual age 16. Pulmonary haemorrhage 17. Pulmonary Interstitial Emphysema 18. Medical treatment for patent ductus arteriosus (PDA) 19. Surgical treatment for PDA 20. Treatment with postnatal corticosteroids 21. Intraventricular haemorrhage 22. Periventricular leukomalacia 23. Sepsis 24. Necrotising Enterocolitis 25. Retinopathy of prematurity 26. Hospital days 27. Death before hospital discharge	—

Measure

Time frame

1. Heart rate at five minutes 2. Use of supplemental oxygen in the DR 3. Chest compressions in the DR 4. Use of adrenaline and volume resuscitation in the delivery room 5. Apgar scores at 5 and 10 minutes 6. Temperature on arrival to NICU 7. Air leak (pneumothorax, pneumopericardium) 8. Intubation and mechanical ventilation =72 hours of life 9. Intubation and mechanical ventilation during hospital stay 10. Surfactant use 11. Duration of mechanical ventilation (hours & days) 12. Duration of CPAP (hours & days) 13. Duration of oxygen therapy (hours & days) 14. Oxygen therapy at 28 days 15. Oxygen therapy at 36 weeks? post-menstrual age 16. Pulmonary haemorrhage 17. Pulmonary Interstitial Emphysema 18. Medical treatment for patent ductus arteriosus (PDA) 19. Surgical treatment for PDA 20. Treatment with postnatal corticosteroids 21. Intraventricular haemorrhage 22. Periventricular leukomalacia 23. Sepsis 24. Necrotising Enterocolitis 25. Retinopathy of prematurity 26. Hospital days 27. Death before hospital discharge

—

Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026