Clinical trial NCT01306227: L-Thyroxine Supplementation for Preterm Newborns Less Than 32 Weeks of Gestation With Hypothyroxinemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2011-03-01
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neurodevelopmental outcome
timeFrame: 2 years old
Secondary outcomes:
measure: Morbidity associated with management of newborns < 32 WG with hypothyroxinemia
timeFrame: discharge, 1 year, 2 years
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
state: Basse Normandie
city: Lens
country: France
facility: Lens Hospital
state: Nord- Pas De Calais
city: Amiens
country: France
facility: Amiens University Hospital
state: Picardie
Study officials:
affiliation: Amiens University Hospital
name: Pierre Tourneux, MD
role: PRINCIPAL_INVESTIGATOR
References: