Study of Thyroid Hormones in Prematures

• Status: Withdrawn
• Trial end date: 2026-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators hypothesize that continuous infusion of 4 µg/Kg/day T4 with 30 µg/Kg/day oral potassium iodide (KI) for 42 days from birth will reduce by 30% or more (from an estimated 30% to 21%) the proportion of extremely low gestational age subjects with a composite endpoint of "cerebral palsy (CP) or a Bayley III Composite Cognitive Score < 85" at 36 months corrected postnatal age (CA).

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: New York Medical College
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Hormones; Iodine

Criteria

Inclusion Criteria:

1. Neonates 24 0/7 to 27 6/7 weeks gestational age

2. inborn or transferred; < 24 hours old

Exclusion Criteria:

1. Maternal or congenital thyroid disease or

2. Maternal substance abuse by history at the time of birth (heroin or cocaine)

3. Major congenital or surgical malformations of neonate

4. Known chromosomal anomalies detected by antepartum testing or direct physical examination

5. Absence of parental consent or treating physician assent

6. A concurrent clinical trial with another randomized drug

7. Death expected < 48h vi) Another concern by the treating physician that either mandates or prohibits study treatment such as known adverse drug interaction

8. mother < 18 years old at delivery