Permissive Hypercapnia and Brain Development in Premature Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Arkansas Children's Hospital Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01361360
First received: May 25, 2011
Last updated: January 18, 2012
Last verified: January 2012
  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:

Estimated Enrollment: 40
Study Start Date: May 2011
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
control
hypercapnia

  Eligibility

Ages Eligible for Study:   3 Months to 5 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361360

Locations
United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72211
Contact: Xiawei Ou, PhD       ouxiawei@uams.edu   
Principal Investigator: Xiawei Ou, PhD         
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
  More Information

No publications provided

Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01361360     History of Changes
Other Study ID Numbers: Thrasher
Study First Received: May 25, 2011
Last Updated: January 18, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014