Biphasic nasal continuous positive airway pressure (CPAP) versus nasal CPAP at extubation
| ISRCTN | ISRCTN94116457 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94116457 |
| Secondary identifying numbers | L09030A |
- 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
Scientific
Consultant Neonatologist
Department of Neonatology
Wishaw General Hospital
50 Netherton street
Wishaw
ML2 0DP
United Kingdom
Study information
| Study design | Prospective open label randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Separate document, approved by ethics committee (no link available now) |
| 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 | 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 study start date | 01/09/2010 |
| Completion date | 30/08/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 120 babies |
| 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
- Scotland
- United Kingdom
Study participating centre
Consultant Neonatologist
Wishaw
ML2 0DP
United Kingdom
ML2 0DP
United Kingdom
Sponsor information
NHS Lanarkshire (UK)
Government
Government
c/o Mr Raymond Hamill
R&D Manager
Monklands Hospital
Monkscourt Avenue
Airdrie
ML6 8LL
United Kingdom
| Website | http://www.nhslanarkshire.org.uk/Pages/default.aspx |
|---|---|
"ROR" |
https://ror.org/049prb569 |
Funders
Funder type
Other
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
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.
