Neurodevelopmental Impact of Treatment in Hypothyroxinaemia of Prematurity.

Transient Hypothyroxinemia of Prematurity Clinical Trial

— NEO-TYR  

Official title:

Neurodevelopmental Impact of Treatment in Hypothyroxinaemia of Prematurity.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06346236
• Other study ID #: 69HCL21_0843
• Secondary ID: 401
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: March 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 373
• Est. completion date: September 1, 2022
• Est. primary completion date: July 1, 2021
• Gender: All
• Age group: N/A to 2 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Transient Hypothyroxinemia of Prematurity

Intervention

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.
• NoTHOP
Subjects diagnosed no-THOP (as previously defined)

Locations

Country	Name	City	State
France	HFME	Bron
France	CHU Grenoble	Grenoble
France	CHU Saint EtienneHopital	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuro-development judged " abnormal " by the paediatrician during the two years of corrected age's consultation.	Neuro-development is evaluated routinely by paediatricians during consultation, and this evaluation is reported in medical files.	Evaluation at two years of corrected age.