Continuous Negative Extrathoracic Pressure in neonatal respiratory failure
- Conditions
- eonatal respiratory failure (respiratory distress syndrome)Neonatal DiseasesRespiratory failure
- Registration Number
- ISRCTN05982584
- Lead Sponsor
- niversity Hospital of North Staffordshire (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 244
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.
Not provided at time of registration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method