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

Centre Hospitalier Universitaire, Amiens

Status and phase: Completed; Phase 3

Conditions: Hypothyroxinemia

Treatments: Drug: water; Drug: L-Thyroxine

Study type: Interventional

Funder types: Other

Identifiers

NCT01306227

PHRCIR07-DR-TOURNEUX

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 1 week to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

water

Placebo Comparator group

Description:

Oral treatment with water for 6 weeks

Treatment:

Drug: water

L-Thyroxine

Experimental group

Description:

Oral treatment with L-Thyroxine for 6 weeks

Treatment:

Drug: L-Thyroxine