Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N0128138699
Study information
Scientific title
Acronym
Study hypothesis
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
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Not Specified
Patient information sheet
Condition
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
Proportion of infants receiving added oxygen and/or respiratory support at 36 weeks post menstrual age.
Secondary outcome measures
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).
Overall study start date
07/10/2003
Overall study end date
01/03/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
200 infants
Participant type(s)
Patient
Age group
Neonate
Sex
Not Specified
Target number of participants
200 infants
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
07/10/2003
Recruitment end date
01/03/2009
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Liverpool Women's Hospital
Liverpool
L8 7SS
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Liverpool Women's Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|