Permissive Hypercapnia and Brain Development in Premature Infants

Completed

• Conditions: Premature Birth

• Registration Number: NCT01361360
• Lead Sponsor: Arkansas Children's Hospital Research Institute

Brief Summary

In the US, every year approximately 30,000 infants are born very prematurely, with birth weight less than 1000 grams. These infants usually require ventilators to help them breath normally during the first few weeks of life. Although the ventilator is lifesaving, it can also injure the very fragile lungs of these infants. Thus, a ventilation strategy, called permissive hypercapnia (high carbon dioxide), is widely used to prevent lung injury. Importantly, there is new research showing that high carbon dioxide may cause brain injury. In our proposed research, we will use magnetic resonance imaging methods to evaluate the brain in 40 very premature infants at term-equivalent age (Half of them had permissive hypercapnia ventilation, the other half did not) to see if permissive hypercapnia has adverse effect on brain development.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-25
• Study First Submitted QC: 2011-05-25
• Study First Posted: 2011-05-26
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-24
• Last Update Posted: 2017-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Premature infants with birth weight 401-1000 g

Exclusion Criteria

• Those with complex congenital anomalies, central nervous system malformations, chromosomal abnormalities, or hydrops fetalis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MRI	0

Trial Locations

Locations (1)

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States