Study of Thyroid Hormones in Prematures

Phase 3 Withdrawn New York Medical College National Institute of Neurological Disorders and Stroke (NINDS) · collab

RandomizedSingle-groupTriple-blindTreatment

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).

Timeline

Start: 2020-07-01
Primary completion: 2025-05
Completion: 2026-05

Outcome

Outcome not reported

Stopped (Business): “not funded by NIH”

Publications

Results La Gamma EF, van Wassenaer AG, Ares S, Golombek SG, Kok JH, Quero J, Hong T, Rahbar MH, de Escobar GM, Fisher DA, Paneth N. Phase 1 trial of 4 thyroid hormone regimens for transient hypothyroxinemia in neonates of <28 weeks' gestation. Pediatrics. 2009 Aug;124(2):e258-68. doi: 10.1542/peds.2008-2837. Epub 2009 Jul 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	T4	Unknown	4 ug/kg	—
Subject	potassium iodide	Small molecule	30 ug/kg	Oral