Status:
WITHDRAWN
Melatonin Treatment for Newborn Infants With Moderate to Severe Hypoxic Ischemic Encephalopathy
Lead Sponsor:
St. Louis University
Conditions:
Newborn Hypoxic Ischemic Encephalopathy
Eligibility:
All Genders
1-8 years
Phase:
PHASE1
Brief Summary
During the birth process certain conditions can cause oxygen delivery and/or blood flow to the baby's brain to become interrupted. This can cause permanent brain damage. Brain damage occurs in two pha...
Detailed Description
This is a double-blind randomized study. All babies less than eight hours old, admitted to the NICU at Cardinal Glennon Children's Medical Center, with moderate to severe HIE that qualify for whole bo...
Eligibility Criteria
Inclusion
- Infants with moderate to severe hypoxic ischemic encephalopathy ≥36 weeks
- First dose of study drug given within 8 hours of birth
Exclusion
- Major chromosomal or congenital defects
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01904786
Start Date
April 1 2014
End Date
November 1 2018
Last Update
July 3 2015
Active Locations (1)
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1
Cardinal Glennnon Children's Medical Center
St Louis, Missouri, United States, 63104