Permissive Hypercapnia in Extremely Low Birthweight Infants

Completed

• Conditions: Infant respiratory distress syndrome; Respiratory; Infant respiratory syndromes

• Registration Number: ISRCTN56143743
• Lead Sponsor: niversity Hospital Ulm (Universitätsklinikum Ulm) (Germany)

Brief Summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26088180 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29662873

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-05
• Study Completion: 2011-12-31
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 830

Inclusion Criteria

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

Exclusion Criteria

Congenital malformations affecting respiratory or cardiac function or requiring surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Bronchopulmonary dysplasia at 36 weeks postmenstrual age<br>2. Death by intention to treat

Secondary Outcome Measures

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