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

Hypothyroxinemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306227
• Other study ID #: PHRCIR07-DR-TOURNEUX
• Status: Completed
• Phase: Phase 3
• Start date: September 1, 2006
• Est. completion date: December 31, 2017

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypothyroxinemia

Intervention

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

Locations

Country	Name	City	State
France	Amiens University Hospital	Amiens	Picardie
France	Caen University Hospital	Caen	Basse Normandie
France	Lens Hospital	Lens	Nord- Pas De Calais

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurodevelopmental outcome	Brunet-Lézine score	2 years old
Secondary	Morbidity associated with management of newborns < 32 WG with hypothyroxinemia	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	discharge, 1 year, 2 years