Biphasic nasal continuous positive airway pressure (CPAP) versus nasal CPAP at extubation

ISRCTN	ISRCTN94116457
DOI	https://doi.org/10.1186/ISRCTN94116457
Protocol serial number	L09030A
Sponsor	NHS Lanarkshire (UK)
Funder	Not provided at time of registration

Submission date: 12/07/2010
Registration date: 06/10/2010
Last edited: 21/08/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sridhar Kalyanasundaram
Scientific

Consultant Neonatologist
Department of Neonatology
Wishaw General Hospital
50 Netherton street
Wishaw
ML2 0DP
United Kingdom

Study information

Primary study design	Interventional
Study design	Prospective open label randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	BiPAP study
Study objectives	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(s)	West of Scotland Regional Ethics Committee (REC) 1, 29/04/2010, ref: 10/S0703/9
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Successful extubation, defined as not meeting reintubation/extubation failure criteria until 72 hours after extubation
Key secondary outcome measure(s)	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
Completion date	30/08/2014

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	120
Total final enrolment	122
Key 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)
Key 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)
Date of first enrolment	01/09/2010
Date of final enrolment	30/08/2014

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Consultant Neonatologist

Wishaw
ML2 0DP
United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	29/05/2019	21/08/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

21/08/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
18/11/2016: No publications found in PubMed, verifying study status with principal investigator.