Continuous Negative Extrathoracic Pressure in neonatal respiratory failure

ISRCTN	ISRCTN05982584
DOI	https://doi.org/10.1186/ISRCTN05982584
Protocol serial number	N/A
Sponsor	University Hospital of North Staffordshire (UK)
Funders	Horner & Wells (UK), Priory Foundation (UK), Dunhill Trust (UK), Moorgate Trust (UK), Little Ones (UK), Queen Charlotte's and Chelsea Hospital (QCCH) (UK) - use of their premises, North Staffordshire Maternity Hospital (NSMH) (UK) - use of their premises

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof David Southall
Scientific

Academic Department of Paediatrics
University Hospital of North Staffordshire
Stoke on Trent
ST4 6QG
United Kingdom

Phone	+44 (0)1782 552575
Email	davids@doctors.org.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/11/1993

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	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

Academic Department of Paediatrics

Stoke on Trent
ST4 6QG
United Kingdom

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/12/1996		Yes	No