Prongs or mask for nasal continuous positive airway pressure (CPAP) in preterm infants

Nasal prongs versus nasal mask for continuous positive airways pressure (CPAP) in preterm infants: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN43000196

Enrollment

120

Registered

2009-09-02

Start date

2009-07-22

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 distress of newborn Respiratory Respiratory distress of newborn

Interventions

Infants starting nasal continuous positive airway pressure (CPAP) using either the Infant Flow Driver or Infant flow SiPAP machine (both made by Viasys Healthcare, Yorba Linda CA, USA) in the neonatal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Infants born less than or equal to 30 weeks' gestation by best obstetric estimate, either sex 2. Receive nasal CPAP using the Infant Flow Driver or SiPAP machine (Viasys, Yorba Linda CA, USA) in the neonatal intensive care unit

Exclusion criteria

Exclusion criteria: Infants with congenital anomalies

Design outcomes

Primary

Measure	Time frame
Intubation and mechanical ventilation less than or equal to 72 hours of starting treatment, indicated by at least two of the five criteria: 1. Worsening clinical respiratory distress 2. Recurrent apnoeic episodes 3. Oxygen requirement greater than 40% to keep oxygen saturations greater than 85% for greater than 30 minutes 4. pH less than 7.2 on two blood gases at least 30 minutes apart 5. Carbon dioxide (PCO2) greater than 9kPa on two blood gases at least 30 minutes apart	—

Measure

Time frame

Intubation and mechanical ventilation less than or equal to 72 hours of starting treatment, indicated by at least two of the five criteria: 1. Worsening clinical respiratory distress 2. Recurrent apnoeic episodes 3. Oxygen requirement greater than 40% to keep oxygen saturations greater than 85% for greater than 30 minutes 4. pH less than 7.2 on two blood gases at least 30 minutes apart 5. Carbon dioxide (PCO2) greater than 9kPa on two blood gases at least 30 minutes apart

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Secondary

Measure	Time frame
1. Use of nasal intermittent positive pressure ventilation (NIPPV), measured at death or hospital discharge 2. Duration of NIPPV (days), measured at death or hospital discharge 3. Number of intubations, measured at death or hospital discharge 4. Doses of surfactant given, measured at death or hospital discharge 5. Duration of mechanical ventilation (in days and hours), measured at death or hospital discharge 6. Duration of CPAP (in days and hours), measured at death or hospital discharge 7. Duration of oxygen therapy (days), measured at death or hospital discharge 8. Oxygen therapy at 28 days 9. Oxygen therapy at 36 weeks' post-menstrual age 10. Highest persistent oxygen requirement on CPAP, measured at death or hospital discharge 11. Home oxygen therapy, measured at hospital discharge 12. Air leaks, measured at death or hospital discharge 13. Use of diuretics, measured at death or hospital discharge 14. Duration of diuretic therapy, measured at death or hospital discharge 15. Sepsis (blood, urine or cerebrospinal fluid culture positivity), measured at death or hospital discharge 16. Medical treatment for patent ductus arteriosus, measured at death or hospital discharge 17. Ligation of patent ductus arteriosus, measured at death or hospital discharge 18. Time to 120 ml/kg/day enteral feeds, measured at death or hospital discharge 19. Gastrointestinal perforation, measured at death or hospital discharge 20. Necrotising enterocolitis, measured at death or hospital discharge 21. Intraventricular haemorrhage, measured at death or hospital discharge 22. Periventricular leukomalacia, measured at death or hospital discharge 23. Retinopathy of prematurity, measured at death or hospital discharge 24. Duration of hospital stay (days), measured at death or hospital discharge 25. Death before discharge and at latest follow-up	—

Measure

Time frame

1. Use of nasal intermittent positive pressure ventilation (NIPPV), measured at death or hospital discharge 2. Duration of NIPPV (days), measured at death or hospital discharge 3. Number of intubations, measured at death or hospital discharge 4. Doses of surfactant given, measured at death or hospital discharge 5. Duration of mechanical ventilation (in days and hours), measured at death or hospital discharge 6. Duration of CPAP (in days and hours), measured at death or hospital discharge 7. Duration of oxygen therapy (days), measured at death or hospital discharge 8. Oxygen therapy at 28 days 9. Oxygen therapy at 36 weeks' post-menstrual age 10. Highest persistent oxygen requirement on CPAP, measured at death or hospital discharge 11. Home oxygen therapy, measured at hospital discharge 12. Air leaks, measured at death or hospital discharge 13. Use of diuretics, measured at death or hospital discharge 14. Duration of diuretic therapy, measured at death or hospital discharge 15. Sepsis (blood, urine or cerebrospinal fluid culture positivity), measured at death or hospital discharge 16. Medical treatment for patent ductus arteriosus, measured at death or hospital discharge 17. Ligation of patent ductus arteriosus, measured at death or hospital discharge 18. Time to 120 ml/kg/day enteral feeds, measured at death or hospital discharge 19. Gastrointestinal perforation, measured at death or hospital discharge 20. Necrotising enterocolitis, measured at death or hospital discharge 21. Intraventricular haemorrhage, measured at death or hospital discharge 22. Periventricular leukomalacia, measured at death or hospital discharge 23. Retinopathy of prematurity, measured at death or hospital discharge 24. Duration of hospital stay (days), measured at death or hospital discharge 25. Death before discharge and at latest follow-up

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Countries

Ireland

Outcome results

None listed

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