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

ISRCTN	ISRCTN68552342
DOI	https://doi.org/10.1186/ISRCTN68552342
Protocol serial number	N0128138699
Sponsor	Department of Health
Funder	Liverpool Women's Hospital NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Richard Cooke
Scientific

Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom

Phone	+44 (0)151 708 9988

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Early intubation and surfactant therapy followed by extubation to NCPAP in preterm infants of less than 29 weeks gestation with RDS when compared to continued intubation and intermittent positive pressure ventilation (IPPV) will result in a 50% reduction in chronic lung disease (CLD) (O2 dependency at 36 weeks post menstrual age).
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Neonatal Diseases: Respiratory
Intervention	Early intubation and surfactant therapy followed by extubation to NCPAP compared with continued intubation and intermittent positive pressure ventilation (IPPV)
Intervention type	Other
Primary outcome measure(s)	Proportion of infants receiving added oxygen and/or respiratory support at 36 weeks post menstrual age.
Key secondary outcome measure(s)	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).
Completion date	01/03/2009

Participant type(s)	Patient
Age group	Neonate
Sex	Not Specified
Target sample size at registration	200
Key inclusion criteria	200 infants
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	07/10/2003
Date of final enrolment	01/03/2009

Liverpool Women's Hospital

Liverpool
L8 7SS
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan