Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
L09030A
Study information
Scientific title
Prospective randomised controlled trial comparing biphasic nasal continuous positive airway pressure (BiPAP) versus nasal continuous positive airway pressure (NCPAP) at extubation of preterm babies
Acronym
BiPAP study
Study hypothesis
The aim of this study is to find out whether two levels of supportive airway pressure (biphasic continuous positive airway pressure [BiPAP]) is better at preventing the baby going back to needing reintubation and mechanical ventilation (avoiding extubation failure) compared to a single level of supportive airway pressure (nasal continuous positive airway pressure [NCPAP]) in preterm babies being taken off (extubated) mechanical ventilation.
Ethics approval
West of Scotland Regional Ethics Committee (REC) 1, 29/04/2010, ref: 10/S0703/9
Study design
Prospective open label randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Separate document, approved by ethics committee (no link available now)
Condition
Respiratory distress in preterm babies; Neonatology
Intervention
Use of Biphasic CPAP or nasal CPAP (based on randomisation) soon after the baby is extubated from mechanical ventilation. Period of intervention first 72 hours post-extubation.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Successful extubation, defined as not meeting reintubation/extubation failure criteria until 72 hours after extubation
Secondary outcome measures
1. Gastrointestnal (GI) complications
2. Total duration on ventilatory support
3. Incidence of Chronic Lung Disease (CLD) (defined as need for oxygen support beyond 28 days/36 weeks corrected gestational age)
4. Incidence and severity of intraventricular haemorrhage (IVH)
5. Time to full feeds
Overall trial start date
01/09/2010
Overall trial end date
30/08/2014
Reason abandoned
Eligibility
Participant inclusion criteria
Babies born between 23 weeks and 0 days and 30 weeks and 6 days gestation who are supported with mechanical ventilation for at least 6 hours in the first 28 days of life (first episode of ventilation only)
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
120 babies
Participant exclusion criteria
Babies with any factor that may affect respiratory effort evident from the initial period, e.g.:
1. Neonatal encephalopathy (involvement of the brain with possible seizures, hypoxic ischaemic encephalopathy [HIE] stage 2 or 3, which is related to perinatal asphyxia)
2. Obvious major birth defects (congenital malformations)
3. Disorders of the muscular system with significant weakness (neuromuscular problems)
Recruitment start date
01/09/2010
Recruitment end date
30/08/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Consultant Neonatologist
Wishaw
ML2 0DP
United Kingdom
Sponsor information
Organisation
NHS Lanarkshire (UK)
Sponsor details
c/o Mr Raymond Hamill
R&D Manager
Monklands Hospital
Monkscourt Avenue
Airdrie
ML6 8LL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Other
Funder name
Not provided at time of registration
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
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary