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NCT01361360 Clinical Trial

Permissive Hypercapnia and Brain Development in Premature Infants

Premature Birth Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01361360
Other study ID # Thrasher
Secondary ID
Status Completed
Phase N/A
First received May 25, 2011
Last updated July 24, 2017
Start date May 2011
Est. completion date October 2016

Study information
Verified date July 2017
Source Arkansas Children's Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 3 Months to 5 Months
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States Arkansas Children's Hospital Little Rock Arkansas

Sponsors (1)
Lead Sponsor Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary MRI 0
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