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

Information source: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypothyroxinemia

Intervention: L-Thyroxine (Drug); water (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Centre Hospitalier Universitaire, Amiens

Official(s) and/or principal investigator(s):
Pierre Tourneux, MD, Principal Investigator, Affiliation: Amiens University Hospital

Overall contact:
Pierre Tourneux, MD, Phone: +33 3 22 66 82 86, Email: tourneux.pierre@chu-amiens.fr

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Neurodevelopmental outcome

Secondary outcome: Morbidity associated with management of newborns < 32 WG with hypothyroxinemia

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

Minimum age: N/A. Maximum age: 5 Years. Gender(s): Both.

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

Locations and Contacts

Pierre Tourneux, MD, Phone: +33 3 22 66 82 86, Email: tourneux.pierre@chu-amiens.fr

Caen University Hospital, Caen, Basse normandie 14033, France; Not yet recruiting
Bernard Guillois, PhD, Phone: +33 2 31 27 25 64, Email: guillois-b@chu-caen.fr
Bernard Guillois, PhD, Principal Investigator

Lens Hospital, Lens, Nord- Pas de calais 62307, France; Not yet recruiting
Serge Klosowski, MD, Phone: +33 3 21 69 11 39, Email: sklosowski@ch-lens.fr
Serge Klosowski, MD, Principal Investigator

Amiens University Hospital, Amiens, Picardie 80054, France; Recruiting
Pierre Tourneux, MD, Phone: +33 3 22 66 82 86, Email: tourneux.pierre@chu-amiens.fr
Bertrand Labattu, Phone: +33 3 22 66 80 63, Email: labattu.bertrand@chu-amiens.fr
Pierre Tourneux, MD, Principal Investigator
Cecile Fontaine, MD, Sub-Investigator
Ghida Ramadan-Ghostine, MD, Sub-Investigator
Helene Bony, MD, Sub-Investigator
Bernard Boudailliez, PhD, Sub-Investigator

Additional Information

Starting date: February 2011
Last updated: September 26, 2011

Page last updated: August 23, 2015

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