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Идёт набор NCT07280104

Infants With Primary Congenital Hypothyroidism and Development

— Наблюдательное Congenital Hypothyroidism

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: neurological status, sensory processing functions, Motor development.
Кому может быть актуально
Состояния в реестре: Congenital Hypothyroidism. Базовые параметры: 6 мес. — 18 мес. · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

Investigation of Development Infants With Primary Congenital Hypothyroidism

Обзор

A review of the literature has focused primarily on the cognitive and motor development of children with congenital hypothyroidism, but no studies on sensory processing skills have been found. Considering the age range of the groups studied, studies conducted in the early stages of life are rare. This planned study aims to examine the neurological status, motor development, and sensory processing skills of infants aged 6-18 months, considering early synaptogenesis.

Подробное описание

The thyroid gland is responsible for producing the hormones necessary for normal growth and development. Congenital hypothyroidism is a condition characterized by underactive or absent thyroid gland in infants. Because thyroid hormone is essential for brain development, these children are at risk for brain damage and related cognitive and motor deficits. Initiating thyroxine supplementation early after birth through newborn screening programs aims to minimize this brain damage. Various studies on the effectiveness of these screening programs have shown that early thyroxine supplementation results in intelligence quotients within the normal range. However, mild cognitive and motor deficits, such as attention and balance problems, are present in most patients.

This planned study aims to examine the neurological status, motor development, and sensory processing skills in infants aged 6-18 months. The results of this study may provide a scientific basis for early follow-up and intervention programs by demonstrating the potential impact of congenital hypothyroidism on these developmental areas.

Вмешательства

  • Поведенческое neurological status
    The Hammersmith Infant Neurological Examination (HINE) was planned to be used to assess the neurological status of infants. The HIND is a standardized examination for children aged 3 to 24 months, with high predictive value in the early detection of neurological disorders.
  • Поведенческое sensory processing functions
    The Test of Sensory Function in Infants (TSFI) was planned to be used to assess infant sensory development. The TSFI is frequently used to assess the sensory processing functions of infants aged 4-18
  • Поведенческое Motor development
    The Peabody Developmental Motor Scales-2 (PDMS-2) was planned to be used to assess motor development. The test is designed to identify developmental delays in children aged 0-72 months.

Первичные конечные точки

  • Motor development [Срок оценки: 6-18 month]
  • Sensory development [Срок оценки: 6-18 months]
  • Neurological Examination [Срок оценки: 6-18 months]

Критерии участия

Критерии включения

  • Those with primary congenital hypothyroidism who have been treated since the newborn period and are currently on treatment.
  • Infants born at term.
  • Between 6 and 18 months old.

Критерии исключения

  • Infants with secondary congenital hypothyroidism,
  • Preterm infants,
  • Those with congenital infections or proven genetic alterations,
  • Infants diagnosed with metabolic, neurological, or genetic diseases,
  • Infants whose parents did not volunteer for the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Turkey (Türkiye) · 1 центр
  • Nigde Omer Halisdemir University — Niğde

Публикации

  • Naafs JC, Marchal JP, Fliers E, Verkerk PH, Luijten MAJ, Boelen A, van Trotsenburg ASP, Zwaveling-Soonawala N. Cognitive and Motor Outcome in Patients with Early-Detected Central Congenital Hypothyroidism Compared with Siblings. J Clin Endocrinol Metab. 2021 Mar 8;106(3):e1231-e1239. doi: 10.1210/clinem/dgaa901. PMID 33274354

Идентификаторы

NCT: NCT07280104 · Congenital hypothyroidism

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗