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Permissive Hypercapnia in Extremely Low Birthweight Infants

Permissive Hypercapnia in Extremely Low Birthweight Infants

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN56143743
Enrollment
830
Registered
2007-01-05
Start date
2007-12-31
Completion date
Unknown
Last updated
2018-05-21

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

Conditions

Infant respiratory distress syndrome Respiratory Infant respiratory syndromes

Interventions

Different PaCO2 target range: Experimental intervention: PaCO2 target range 55 to 65 mmHg (day one to three of life) , 60 to 70 mmHg (day four to six), 65 to 75 mmHg (day seven to 14). Control inter

Sponsors

University Hospital Ulm (Universitätsklinikum Ulm) (Germany)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Extremely low birthweight infants (400 g to 1000 g) requiring mechanical ventilation within 24 hours after birth

Exclusion criteria

Exclusion criteria: Congenital malformations affecting respiratory or cardiac function or requiring surgery

Design outcomes

Primary

MeasureTime frame
1. Bronchopulmonary dysplasia at 36 weeks postmenstrual age 2. Death by intention to treat

Secondary

MeasureTime frame
1. Incidence of intracranial haemorrhages 2. Incidence of air leaks 3. Duration of mechanical ventilation 4. Positive pressure support and supplemental oxygen 5. Inflammatory mediators in tracheal aspirates 6. Neurodevelopmental outcome at 18 to 24 months corrected age, per protocol ananlysis of primary outcome

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 17, 2026