Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Permissive Hypercapnia and Brain Development in Premature Infants

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01361360
First received: May 25, 2011
Last updated: January 13, 2015
Last verified: January 2015
  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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2011
Estimated Primary Completion Date: May 2016 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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 13, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on March 01, 2015