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Permissive Hypercapnia and Brain Development in Premature Infants

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute Identifier:
First received: May 25, 2011
Last updated: August 4, 2016
Last verified: April 2016
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.

Premature Birth

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Further study details as provided by Arkansas Children's Hospital Research Institute:

Primary Outcome Measures:
  • MRI [ Time Frame: 0 ]

Estimated Enrollment: 40
Study Start Date: May 2011
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   3 Months to 5 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Premature infants with birth weight 401-1000 g (gestational age < 30 weeks)

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01361360

United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72211
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
  More Information

Responsible Party: Arkansas Children's Hospital Research Institute Identifier: NCT01361360     History of Changes
Other Study ID Numbers: Thrasher
Study First Received: May 25, 2011
Last Updated: August 4, 2016

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications processed this record on July 19, 2017