Neurodevelopmental Impact of Treatment in Hypothyroxinaemia of Prematurity.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

373 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2022-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Transient Hypothyroxinemia of Prematurity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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THOP treated

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)

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

Intervention Type 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 un-treated

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.

THOP without treatment

Intervention Type OTHER

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

No-THOP

all level of circulating T4 \> 12 pmol/L at any time in life

NoTHOP

Intervention Type OTHER

Subjects diagnosed no-THOP (as previously defined)

Interventions

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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.

Intervention Type DRUG

THOP without treatment

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

Intervention Type OTHER

NoTHOP

Subjects diagnosed no-THOP (as previously defined)

Intervention Type OTHER

Eligibility Criteria

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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

Maximum Eligible Age

2 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No