drugset / Trial / NCT03390530
Thyroxine Treatment in Premature Infants With Intraventricular Hemorrhage
Phase 3
Withdrawn
Albert Einstein College of Medicine
Arkansas Children's Hospital Research Institute · collabBrigham and Women's Hospital · collabChildren's Hospitals and Clinics of Minnesota · collabMorgan Stanley Children's Hospital · collabSt. Louis University · collabUniversity of Minnesota · collabUniversity of North Carolina, Chapel Hill · collabUniversity of Pittsburgh · collabWake Forest University Health Sciences · collabWestchester Medical Center · collab
RandomizedParallel-groupQuadruple-blindTreatment
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, investigators will test whether thyroxine (hormone from thyroid gland) treatment in premature infants with moderate-to-large brain bleeds show recovery in the brain structure on MRI evaluation at the time of discharge (44+/-1 weeks) and neurodevelopmental improvement at 2 years of age.
Timeline
- Start
- 2022-01-18
- Primary completion
- 2025-12-18
- Completion
- 2027-01-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Levothyroxine | Other / unclassified | 8 ug/kg | Intravenous |