Overview

This trial is active, not recruiting.

Condition premature birth
Sponsor Arkansas Children's Hospital Research Institute
Start date May 2011
End date May 2016
Trial size 40 participants
Trial identifier NCT01361360, Thrasher

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm

Primary Outcomes

Measure
MRI
time frame: 0

Eligibility Criteria

Male or female participants from 3 months up to 5 months old.

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

Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Arkansas Children's Hospital Research Institute.