Overview

This trial is active, not recruiting.

Condition hypothyroxinemia
Treatments l-thyroxine, water
Phase phase 3
Sponsor Centre Hospitalier Universitaire, Amiens
Start date February 2011
End date December 2014
Trial size 50 participants
Trial identifier NCT01306227, PHRCIR07-DR-TOURNEUX

Summary

Transient hypothyroxinemia of prematurity (THOP) is associated with neurodevelopmental impairment in preterm newborns < 32 weeks of gestation (WG). It is not known whether L-Thyroxine supplementation for preterm newborns <32 WG with THOP is beneficial.

The purpose of this study is to compare L-thyroxine treatment vs. placebo in newborn less than 32 WG with THOP.

The primary endpoint is the neurodevelopmental outcome at two years of life, assessed by the Brunet-Lézine score. The secondary endpoints are: death, bronchopulmonary dysplasia (oxygen therapy at 28 days of life and at 36 weeks of postnatal age), patent ductus arteriosus, shock requiring fluid loading or vasoactive treatments, enterocolitis, intraventricular hemorrhage, retinopathy of prematurity, deafness.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Oral treatment with water for 6 weeks
water
Oral treatment with water. Equal number of drop of water as compared with the treatment arm (according to the body weight of the newborn) in the morning, once a day.
(Experimental)
Oral treatment with L-Thyroxine for 6 weeks
l-thyroxine
Treatment with L-Thyroxine:7,5 µg/kg/day. Oral treatment (one drop =5µg) in the morning, once a day.

Primary Outcomes

Measure
Neurodevelopmental outcome
time frame: 2 years old

Secondary Outcomes

Measure
Morbidity associated with management of newborns < 32 WG with hypothyroxinemia
time frame: discharge, 1 year, 2 years

Eligibility Criteria

Male or female participants up to 5 years old.

Inclusion Criteria: - Gestational age < 32 WG - FT4 (5, 6 or 7 days of life) ≤ 0.8 ng/dL - TSH (5, 6 or 7 days of life) < 20 mIU/L - Written consent from the parents Exclusion Criteria: - Maternal thyroid disease - FT4 (5, 6 or 7 days of life) > 0.8 ng/dL - TSH (5, 6 or 7 days of life) > 20 mIU/L - Grade III or IV intracerebral hemorrhage

Additional Information

Official title L-Thyroxine Supplementation for Preterm Newborns Less Than 32 Weeks of Gestation With Transient Hypothyroxinemia of Prematurity: a Prospective Randomized Double-blind Trial
Principal investigator Pierre Tourneux, MD
Description Preterm newborns <32 weeks of gestation (WG) are screened for THOP between day 5 and day 7 of life. THOP is defined by thyroid-stimulating hormone (TSH) < 20 mIU/L and FT4 < 0.80 ng/dL. After obtaining written consent from the parents, preterm newborns <32 WG with THOP will be included. Randomization is stratified by center and 2 age-groups (24-28 WG and 29-32 WG). One arm will receive L-thyroxine treatment and the other arm will receive placebo. Treatment will be started within one week after diagnosis and will last 6 weeks. TSH and FT4 will be assayed 2 weeks after stopping treatment. The primary endpoint is the neurodevelopmental outcome at two years of life, assessed by the Brunet-Lézine score.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire, Amiens.