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OpenTrials
Completed

NCT Number: NCT01361360

Permissive Hypercapnia and Brain Development in Premature Infants

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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Key information

Age range

3 month–5 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Arkansas Children's Hospital

Little Rock, Arkansas, 72211, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. MRI

Sponsors and collaborators

Lead sponsor

Arkansas Children's Hospital Research Institute

Other

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
May 26, 2011
Registry last updated
Jul 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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