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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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|
- Neurodevelopmental outcome [ Time Frame: 2 years old ] [ Designated as safety issue: Yes ]Brunet-Lézine score
- Morbidity associated with management of newborns < 32 WG with hypothyroxinemia [ Time Frame: discharge, 1 year, 2 years ] [ Designated as safety issue: Yes ]
- 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
- Intraventricular hemorrhage
- Retinopathy of prematurity
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||December 2017|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: water
Oral treatment with water for 6 weeks
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.
Oral treatment with L-Thyroxine for 6 weeks
Treatment with L-Thyroxine:7,5 µg/kg/day. Oral treatment (one drop =5µg) in the morning, once a day.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306227
|Caen University Hospital|
|Caen, Basse normandie, France, 14033|
|Lens, Nord- Pas de calais, France, 62307|
|Amiens University Hospital|
|Amiens, Picardie, France, 80054|
|Principal Investigator:||Pierre Tourneux, MD||Amiens University Hospital|