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Permissive Hypercapnia and Brain Development in Premature Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01361360
First Posted: May 26, 2011
Last Update Posted: July 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute
  Purpose
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.

Condition
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 ]

Enrollment: 10
Study Start Date: May 2011
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
control
hypercapnia

  Eligibility

Information from the National Library of Medicine

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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)
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361360


Locations
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
ClinicalTrials.gov Identifier: NCT01361360     History of Changes
Other Study ID Numbers: Thrasher
First Submitted: May 25, 2011
First Posted: May 26, 2011
Last Update Posted: July 25, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications