Condition category
Respiratory
Date applied
12/07/2010
Date assigned
06/10/2010
Last edited
18/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sridhar Kalyanasundaram

ORCID ID

Contact details

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

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

http://www.nhslanarkshire.org.uk/Pages/default.aspx

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

Publication citations

Additional files

Editorial Notes

18/11/2016: No publications found in PubMed, verifying study status with principal investigator.