Continuous Negative Extrathoracic Pressure in neonatal respiratory failure
| ISRCTN | ISRCTN05982584 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05982584 |
| Secondary identifying numbers | N/A |
- Submission date
- 08/03/2004
- Registration date
- 09/03/2004
- Last edited
- 24/08/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof David Southall
Scientific
Scientific
Academic Department of Paediatrics
University Hospital of North Staffordshire
Stoke on Trent
ST4 6QG
United Kingdom
| Phone | +44 (0)1782 552575 |
|---|---|
| davids@doctors.org.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | CNEP |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Neonatal respiratory failure (respiratory distress syndrome) |
| Intervention | Patients were randomised at four hours of age to receive either standard neonatal intensive care, or standard care plus continuous negative extrathoracic pressure (CNEP, -4 to -6 cm H2O) applied within a purpose-designed neonatal incubator. |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/10/1989 |
| Completion date | 01/11/1993 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 244 |
| Key inclusion criteria | The trial was undertaken in two neonatal intensive care units, Queen Charlotte's and Chelsea Hospital (QCCH) and North Staffordshire Maternity Hospital (NSMH), between October 1989 and November 1993. There were 244 patients: birth weight 1.53 ± 0.69 kg (mean ± SD), gestational age 30.4 ± 3.5 weeks, with respiratory failure. Patients were considered for entry at 2 hours of age if they required additional inspired oxygen or ventilation to maintain an arterial partial pressure of oxygen (PO2) of ≥8 kPa (60 mm Hg: conversion factor 7.5) or an arterial partial pressure of carbon dioxide (PCO2) of <6.5 kPa at Queen Charlotte's and Chelsea Hospital (QCCH) or 8 kPa at North Staffordshire Maternity Hospital (NSMH). This latter difference was because the two participating units had different practices at the time the trial commenced. Patients were randomised if, after a second assessment at 4 hours of age, they required ≥40% inspired oxygen or ventilation to maintain these blood gas measurements. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/1989 |
| Date of final enrolment | 01/11/1993 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Department of Paediatrics
Stoke on Trent
ST4 6QG
United Kingdom
ST4 6QG
United Kingdom
Sponsor information
University Hospital of North Staffordshire (UK)
Government
Government
Newcastle Road
Stoke on Trent
ST4 6QG
United Kingdom
| Phone | +44 (0)1782 715444 |
|---|---|
| info@uhns.nhs.uk |
Funders
Funder type
Charity
Horner & Wells (UK)
No information available
Priory Foundation (UK)
No information available
Dunhill Trust (UK)
No information available
Moorgate Trust (UK)
No information available
Little Ones (UK)
No information available
Queen Charlotte's and Chelsea Hospital (QCCH) (UK) - use of their premises
No information available
North Staffordshire Maternity Hospital (NSMH) (UK) - use of their premises
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 | 01/12/1996 | Yes | No |
