A randomised controlled trial of nasal constant positive airway pressure (NCPAP) as primary therapy for respiratory distress syndrome (RDS) in very pre-term infants.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN68552342

Enrollment

200

Registered

2004-09-30

Start date

2003-10-07

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

Neonatal Diseases: Respiratory Neonatal Diseases Respiratory

Interventions

Early intubation and surfactant therapy followed by extubation to NCPAP compared with continued intubation and intermittent positive pressure ventilation (IPPV)

Eligibility

Inclusion criteria

Inclusion criteria: 200 infants

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

Measure	Time frame
Proportion of infants receiving added oxygen and/or respiratory support at 36 weeks post menstrual age.	—

Secondary

Measure	Time frame
1. Days of respiratory support 2. Days of added oxygen 3. Death 4. Pneumothorax rate 5. Sepsis rate (positive blood culture) 6. Trauma rates (nasal septal injury, tracheal stenosis) 7. Change in weight and head circumference centiles between birth and discharge (Z scores).	—

Countries

United Kingdom

Outcome results

None listed

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