Thyroxine Treatment in Premature Infants With Intraventricular Hemorrhage

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.

Conditions

• Intraventricular Hemorrhage of Prematurity

Interventions

DRUG

Thyroxine

8 µg/kg/day divided into two doses intravenous every 12 hours

DRUG

Placebo

Placebo

Sponsors & Collaborators

• Westchester Medical Center

  collaborator OTHER

• Morgan Stanley Children's Hospital

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• Children's Minnesota Hospital

  collaborator UNKNOWN

• University of Minnesota

  collaborator OTHER

• St. Louis University

  collaborator OTHER

• Arkansas Children's Hospital Research Institute

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• University of North Carolina, Chapel Hill

  collaborator OTHER

• Wake Forest University Health Sciences

  collaborator OTHER

• Albert Einstein College of Medicine

  lead OTHER

Principal Investigators

• PRAVEEN BALLABH, MD · Albert Einstein College of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

3 Days

Max Age

6 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-18

Primary Completion

2025-12-18

Completion

2027-01-18

FDA Drug

Yes

Countries

• United States

Study Locations