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Neurodevelopmental Impact of Treatment in Hypothyroxinaemia of Prematurity.

Neurodevelopmental Impact of Treatment in Hypothyroxinaemia of Prematurity.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06346236
Acronym
NEO-TYR
Enrollment
373
Registered
2024-04-03
Start date
2020-03-01
Completion date
2022-09-01
Last updated
2024-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transient Hypothyroxinemia of Prematurity

Keywords

transient hypothyroxinaemia of prematurity, THOP, preterm, prematurity, neurodevelopment, L-thyroxine, ASQ score

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.

Interventions

DRUGL-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.

OTHERTHOP without treatment

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

OTHERNoTHOP

Subjects diagnosed no-THOP (as previously defined)

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 2 Weeks

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

Design outcomes

Primary

MeasureTime frameDescription
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026