Study of Thyroid Hormones in Prematures

Withdrawn before enrolling · Phase 3

Conditions studied: Transient Hypothyroxinemia of Prematurity (THOP)

In brief

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).

Key facts

Study ID

NCT02103998

Run by

New York Medical College

People needed

0

Starts

2020-07-01

Expected to finish

2026-05-01

Last updated by the study team

2019-04-24

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Neonates 24 0/7 to 27 6/7 weeks gestational age
• inborn or transferred; < 24 hours old

You may not qualify if…

• Maternal or congenital thyroid disease or
• Maternal substance abuse by history at the time of birth (heroin or cocaine)
• Major congenital or surgical malformations of neonate
• Known chromosomal anomalies detected by antepartum testing or direct physical examination
• Absence of parental consent or treating physician assent
• A concurrent clinical trial with another randomized drug
• Death expected < 48h vi) Another concern by the treating physician that either mandates or prohibits study treatment such as known adverse drug interaction
• mother < 18 years old at delivery

Where it is running

• Maria Fareri Childrens Hospital — Valhalla, New York, United States

Full record on ClinicalTrials.gov

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