L-Thyroxine Supplementation for Preterm Newborns Less Than 32 Weeks of Gestation With Hypothyroxinemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-01

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypothyroxinemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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water

Oral treatment with water for 6 weeks

Group Type PLACEBO_COMPARATOR

water

Intervention Type DRUG

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.

L-Thyroxine

Oral treatment with L-Thyroxine for 6 weeks

Group Type EXPERIMENTAL

L-Thyroxine

Intervention Type DRUG

Treatment with L-Thyroxine:7,5 µg/kg/day. Oral treatment (one drop =5µg) in the morning, once a day.

Interventions

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L-Thyroxine

Treatment with L-Thyroxine:7,5 µg/kg/day. Oral treatment (one drop =5µg) in the morning, once a day.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

1 Week

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No