Permissive Hypercapnia and Brain Development in Premature Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2016-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Premature Birth

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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control

No interventions assigned to this group

hypercapnia

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

3 Months

Maximum Eligible Age

5 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Arkansas Children's Hospital

Little Rock, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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Thrasher

Identifier Type: -

Identifier Source: org_study_id

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