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

L-Thyroxine Supplementation for Preterm Newborns Less Than 32 Weeks of Gestation With Transient Hypothyroxinemia of Prematurity: a Prospective Randomized Double-blind Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01306227

Enrollment

Registered

2011-03-01

Start date

2006-09-01

Completion date

2017-12-31

Last updated

2018-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothyroxinemia

Keywords

Infant, newborn, Infant, preterm, Thyroid, Outcome, Newborns less than 32 weeks of gestation, TSH < 20 mIU/L and a FT4 < 0.80 ng/dL

Brief 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.

Detailed 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.

Interventions

DRUGL-Thyroxine

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

DRUGwater

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Weeks to 5 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Neurodevelopmental outcome	2 years old	Brunet-Lézine score

Secondary

Measure	Time frame	Description
Morbidity associated with management of newborns < 32 WG with hypothyroxinemia	discharge, 1 year, 2 years	* 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026