Neurodevelopmental Impact of Treatment in Hypothyroxinaemia of Prematurity.

Completed

• Conditions: Transient Hypothyroxinemia of Prematurity
• Interventions: Drug: L-thyroxine at a dose of 7.5 µg/kg/d for THOP; Other: THOP without treatment; Other: NoTHOP

• Registration Number: NCT06346236
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2021-07-01
• Study Completion: 2022-09-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-03-28
• Last Update Submitted: 2024-03-28
• Study First Posted: 2024-04-03
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 373

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
THOP treated	L-thyroxine at a dose of 7.5 µg/kg/d for THOP	Level of circulating T4 \< 12 pmol/L at any time of life associated, on the same date, with a level of circulatingon thyro-stimulating hormone \< 15 mUI/L if the sample was realiszed before or on the fifteenth day of life OR \< 58 mUI/L if the sample was realiszed after the fifteenth day of life, and L-thyroxine treatment is recorded in the medical record (at any dose and with any duration)
THOP un-treated	THOP without treatment	Level of circulating T4 \< 12 pmol/L at any time of life associated, on the same date, with a level of circulation thyro-stimulating hormone \< 15 mUI/L if sample was realiszed before or on the fifteenth day of life OR \< 5 mUI/L if sample was realiszed after the fifteenth day of life, and no L-thyroxine treatment recorded in the medical record.
No-THOP	NoTHOP	all level of circulating T4 \> 12 pmol/L at any time in life

Primary Outcome Measures

Name	Time	Method
Neuro-development judged " abnormal " by the paediatrician during the two years of corrected age's consultation.	Evaluation at two years of corrected age.	Neuro-development is evaluated routinely by paediatricians during consultation, and this evaluation is reported in medical files.

Trial Locations

Locations (3)

CHU Saint EtienneHopital; 🇫🇷 Saint-Étienne, France

HFME; 🇫🇷 Bron, France

CHU Grenoble; 🇫🇷 Grenoble, France