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Completed

NCT Number: NCT01306227

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

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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Key information

Conditions

Hypothyroxinemia Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Thyroid Diseases Urogenital Diseases

Age range

1 week–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Caen University Hospital, Caen, Basse Normandie, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L-Thyroxine

Drug

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

Water

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.

Primary outcomes

  1. Neurodevelopmental outcome

    Time frame: 2 years old

    Brunet-Lézine score

Secondary outcomes

  1. Morbidity associated with management of newborns < 32 WG with hypothyroxinemia

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2014
Study completion
2017
First posted
Mar 1, 2011
Registry last updated
Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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