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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Completed

CT.gov ID

NCT01306227

Collaborator

(none)

Enrollment

Locations

Arms

136

Actual Duration (Months)

16.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypothyroxinemia	Drug: L-Thyroxine Drug: water	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Dec 31, 2014

Actual Study Completion Date :

Dec 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: water Oral treatment with water for 6 weeks	Drug: 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.
Experimental: L-Thyroxine Oral treatment with L-Thyroxine for 6 weeks	Drug: L-Thyroxine Treatment with L-Thyroxine:7,5 µg/kg/day. Oral treatment (one drop =5µg) in the morning, once a day.

Arm

Intervention/Treatment

Placebo Comparator: water

Oral treatment with water for 6 weeks

Drug: 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.

Experimental: L-Thyroxine

Oral treatment with L-Thyroxine for 6 weeks

Drug: L-Thyroxine

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

Outcome Measures

Primary Outcome Measures

Neurodevelopmental outcome [2 years old]
Brunet-Lézine score

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Week to 5 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Caen University Hospital	Caen	Basse Normandie	France	14033
2	Lens Hospital	Lens	Nord- Pas De Calais	France	62307
3	Amiens University Hospital	Amiens	Picardie	France	80054