Skip to main content
OpenTrials
Completed

NCT Number: NCT06346236

Neurodevelopmental Impact of Treatment in Hypothyroxinaemia of Prematurity.

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

Up to 2 week

Sex eligibility

All sexes

Study type

Observational

Primary location

HFME, Bron, France

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Premature infants born before or at 3032 weeks of gestation
  • For whom blood sample for thyroid examination has been performed for routine care during his stay in neonatology unit.

Exclusion criteria

  • Other type of thyroid dysfunction (including, but not exclusively: mother with Basedow disease, congenital hypothyroidism, hyperthyroidism)
  • Associated polymalformative sindrome

Treatment and study plan

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

Drug

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.

THOP without treatment

Other

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

NoTHOP

Other

Subjects diagnosed no-THOP (as previously defined)

Primary outcomes

  1. Neuro-development judged " abnormal " by the paediatrician during the two years of corrected age's consultation.

    Time frame: Evaluation at two years of corrected age.

    Neuro-development is evaluated routinely by paediatricians during consultation, and this evaluation is reported in medical files.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: NEO-TYR

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 3, 2024
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.