NCT06346236

Neurodevelopmental Impact of Treatment in Hypothyroxinaemia of Prematurity.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 373 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 2 Weeks
• Healthy volunteers: —

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

Type	Name	Description
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)

Timeline

• Start date: 2020-03-01
• Primary completion: 2021-07-01
• Completion: 2022-09-01
• First posted: 2024-04-03
• Last updated: 2024-04-03

Locations

3 sites across 1 country: France