Status:
WITHDRAWN
Thyroxine Treatment in Premature Infants With Intraventricular Hemorrhage
Lead Sponsor:
Albert Einstein College of Medicine
Collaborating Sponsors:
Westchester Medical Center
Morgan Stanley Children's Hospital
Conditions:
Intraventricular Hemorrhage of Prematurity
Eligibility:
All Genders
3-6 years
Phase:
PHASE3
Brief Summary
Brain bleed in premature infants damages the brain and survivors suffer from cerebral palsy (weakness in the extremities), cognitive deficits, and neurobehavioral disorders. In this clinical trial, in...
Detailed Description
Intraventricular hemorrhage (IVH) remains a major complication of prematurely born infants. Survivors of IVH suffer from cerebral palsy, cognitive deficits and neurobehavioral disorders. In the propos...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- NICU inpatients born between 23-0/7 and 27-6/7 weeks of gestation
- Postnatal age 3-6days (≥3 d ≤ 6 d)
- Unilateral or bilateral Grade 3 or 4 IVH
- Parental consent
- Exclusion criteria:
- Major malformations, including surgical, cardiac, cerebral, chromosomal, or genetic syndromes, identifiable at or before birth;
- Congenital bacterial infection proven by culture at birth or viral syndrome known prior to delivery (e.g. chicken pox, rubella, etc.)
Exclusion
Key Trial Info
Start Date :
January 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03390530
Start Date
January 18 2022
End Date
January 18 2027
Last Update
July 8 2022
Active Locations (1)
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1
Praveen Ballabh
The Bronx, New York, United States, 10461