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

NCT01306227 | Completed Phase 3 DMC

• 1 other identifier: PHRCIR07-DR-TOURNEUX
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (1)

• Neurodevelopmental outcome

  Brunet-Lézine score

  2 years old

Secondary Outcomes (1)

• Morbidity associated with management of newborns < 32 WG with hypothyroxinemia

  discharge, 1 year, 2 years

Study Arms (2)

water

PLACEBO COMPARATOR

Oral treatment with water for 6 weeks

Drug: water

L-Thyroxine

EXPERIMENTAL

Oral treatment with L-Thyroxine for 6 weeks

Drug: L-Thyroxine

Interventions

L-Thyroxine DRUG

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

L-Thyroxine

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.

water

Eligibility Criteria

• Age: 1 Week - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (3)

Caen University Hospital

Caen, Basse Normandie, 14033, France

Location

Lens Hospital

Lens, Hauts-de-France, 62307, France

Location

Amiens University Hospital

Amiens, Picardie, 80054, France

Location

MeSH Terms

Conditions

Premature Birth; Thyroid Diseases

Interventions

Thyroxine; Water

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Pierre Tourneux, MD

  Amiens University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2011
• First Posted: March 1, 2011
• Study Start: September 1, 2006
• Primary Completion: December 31, 2014
• Study Completion: December 31, 2017
• Last Updated: August 10, 2018

Record last verified: 2018-08

Locations

FR (3)