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Continuous Negative Extrathoracic Pressure in neonatal respiratory failure

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN05982584
Enrollment
244
Registered
2004-03-09
Start date
1989-10-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal respiratory failure (respiratory distress syndrome) Neonatal Diseases Respiratory failure

Interventions

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 withi

Sponsors

University Hospital of North Staffordshire (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

MeasureTime frame
Not provided at time of registration

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026