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Randomised controlled trial of Bubble CPAP versus infant flow driver for successful extubation in preterm infants

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN83339638
Enrollment
118
Registered
2006-09-29
Start date
2004-10-01
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 Diseases: Respiratory Neonatal Diseases Respiratory

Interventions

Babies up to 30 week gestation and requiring ventilatory support would be eligible for study pre-extubation. Signed informed parental consent will be sought before randomisation.Babies will be random

Sponsors

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Born between 24 and less than 30 weeks gestation, or with a birth weight of 600 to 1500 grams 2. Endotracheal intubation for any duration 3. Stable or improving respiratory status with inspired oxygen concentration of less than 50% 4. First extubation attempt 5. Signed parental consent 6. Considered ready for extubation by the clinical management team

Exclusion criteria

Exclusion criteria: 1. Major congenital malformations, which are known to adversely affect life expectancy 2. Known congenital or acquired upper airway obstruction 3. Neuromuscular disorders

Design outcomes

Primary

MeasureTime frame
Respiratory failure within 72 hours defined as: 1. Need for re-intubation primarily for respiratory distress AND/OR 2. Uncompensated Respiratory Acidosis (pH8kPa

Secondary

MeasureTime frame
1. Endotracheal reintubation 2. Duration of CPAP days 3. Chronic Lung Disease, Morbidity, Mortality and Data on complications including gastrointestinal will be collected.

Countries

United Kingdom

Outcome results

None listed

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