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Continuous Negative Extrathoracic Pressure in neonatal respiratory failure

Completed
Conditions
eonatal respiratory failure (respiratory distress syndrome)
Neonatal Diseases
Respiratory 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
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.

Exclusion Criteria

Not provided at time of registration

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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