MedTrace Logo

Neurodevelopmental Impact of Treatment in Hypothyroxinaemia of Prematurity.

NCT06346236 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 373

Last updated 2024-04-03

No results posted yet for this study

Summary

Nowadays, taking care of preterm birth is associated with an important increase in survival. This increased survival comes with impairment in neurodevelopmental outcomes in long term evaluation. Thyroid hormones are essentials for brain development, especially for neuronal differentiation. Transient hypothyroxinaemia of prematurity (THOP) is a frequent condition defined by decreased thyroid hormones without the expected rise in thyroid stimulating hormone. Various studies have showed various results regarding the consequences of THOP on neurodevelopment in premature neonates. However, the biggest and most powerful studies agree to say that THOP impair neurodevelopment. On the other hand, only a few studies evaluated the impact of treatment of THOP, and only two focused on treating exclusively the neonates with a biological diagnosis of THOP (Suzumura and co. in 2010 and Nomura and co. in 2014) and their results are inconsistent.

In this study, we aim to show that a treatment with L-thyroxine at a dose of 7.5 µg/kg/j for neonates diagnosed with THOP (defined as a level of l-T4 \< 12 pmol/L and a level of TSH \< 15 mUI/L before 15 days of life or \< 85 mUI/L after 15 days of birth) is associated with an increased neurodevelopmental prognosis.

Conditions

  • Transient Hypothyroxinemia of Prematurity

Interventions

DRUG

L-thyroxine at a dose of 7.5 µg/kg/d for THOP

Subjects diagnosed with THOP (as previously defined) and treated with L-thyroxine at a dose of 7.5 µg/kg/d are less likely to have an impaired ASQ score at 4 years of corrected age.

OTHER

THOP without treatment

Subjects diagnosed with THOP (as previously defined) and who received no L-thyroxine treatment.

OTHER

NoTHOP

Subjects diagnosed no-THOP (as previously defined)

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Eligibility

Max Age
2 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2021-07-01
Completion
2022-09-01

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06346236 on ClinicalTrials.gov