Effect of L-Thyroxine supplementation in the first weeks of life on long-term neurodevelopmental outcome in infants with transient hypothyroxinemia born at or less than 28 weeks’ gestatio

• Conditions: infants with transient hypothyroxinemia born at or less than 28 weeks’ gestation; MedDRA version: 14.1Level: PTClassification code 10043816Term: Thyroxine decreasedSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2010-021228-89-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-05
• Last Update Posted: 24 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) gestational age at or less 28 weeks 2) postnatal serum fT4 levels below a cutoff value of appropriate ranges of cord levels corrected to an equivalent gestational age and TSH values less than 10 mU/L 3) obtained signed informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range: 130
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) known or suspected hyperergia to the drug 2) severe congenital malformations or clinical conditions that contraindicate the participation in the trial 3) known adrenal insufficiency 4) maternal thyroid disease or illicit-drug use by the mother

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified