WithdrawnPhase 3

Study of Thyroid Hormones in Prematures

Stopped: not funded by NIH

United States0Started 2020-07-01

Plain-language 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).

Who can participate

Age range1 Hour – 24 Hours

SexALL

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Inclusion criteria

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

Exclusion criteria

✕. 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

What they're measuring

Compare incidence of a COMPOSITE endpoint of "cerebral palsy (CP) or a Bayley III Composite Cognitive Score < 85" at 36 months corrected postnatal age (CA).

Timeframe: 36 months

Trial details

NCT IDNCT02103998

SponsorNew York Medical College

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05

View on ClinicalTrials.gov More Transient Hypothyroxinemia of Prematurity (THOP) trials