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’ gestation

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’ gestation - CICO-10-01

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021228-89-IT

Enrollment

130

Registered

2012-03-05

Start date

2011-04-22

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

infants with transient hypothyroxinemia born at or less than 28 weeks’ gestation MedDRA version: 14.1 Level: PT Classification code 10043816 Term: Thyroxine decreased System Organ Class: 10022891 - Investigations

Interventions

Product Name: L-Tyroxin sodium Product Code: NA Pharmaceutical Form: Solution for injection INN or Proposed INN: Levothyroxine sodium Concentration unit: µg/ml microgram(s)/millilitre Concentration n

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: to evaluate with a randomized, placebo-controlled trial the efficacy of thyroxine supplementation in the first weeks of life in term of psychomotor development and mental outcome at 24 months of corrected age in preterm infants with gestational age at or less 28 weeks;Secondary Objective: 1) to evaluate the safety/tolerability of the experimental treatment 2) to evaluate on the selected population the effects of the therapy on thyroid hormone levels, on mortality and morbidity , on psychomotor and mental developmental at 6 and 12 months of corrected age 3) to evaluate the possible influence of gestational age, initial level of fT4, gender, intercurrent illness and iatrogenic effects on the therapeutic effectiveness of L-thyroxine;Primary end point(s): mental and psychomotor development scores (assessed by Griffiths Mental Developmental Scales) at the final assessment at 24 months of corrected age significantly better in thyroxine-treated infants than in placebo group.;Timepoint(s) of evaluation of this end point: pharmacological treatment 6 weeks, follow-up 2 years	—

Measure

Time frame

Main Objective: to evaluate with a randomized, placebo-controlled trial the efficacy of thyroxine supplementation in the first weeks of life in term of psychomotor development and mental outcome at 24 months of corrected age in preterm infants with gestational age at or less 28 weeks;Secondary Objective: 1) to evaluate the safety/tolerability of the experimental treatment 2) to evaluate on the selected population the effects of the therapy on thyroid hormone levels, on mortality and morbidity , on psychomotor and mental developmental at 6 and 12 months of corrected age 3) to evaluate the possible influence of gestational age, initial level of fT4, gender, intercurrent illness and iatrogenic effects on the therapeutic effectiveness of L-thyroxine;Primary end point(s): mental and psychomotor development scores (assessed by Griffiths Mental Developmental Scales) at the final assessment at 24 months of corrected age significantly better in thyroxine-treated infants than in placebo group.;Timepoint(s) of evaluation of this end point: pharmacological treatment 6 weeks, follow-up 2 years

—

Secondary

Measure	Time frame
Secondary end point(s): Na;Timepoint(s) of evaluation of this end point: Na	—

Countries

Italy

Contacts

Public ContactU.O. Pediatria (Cicognani)

AOU di Bologna, Policlinico S.Orsola

alessandro.cicognani@unibo.it0516364814

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026