NCT07280104

Infants With Primary Congenital Hypothyroidism and Development

Investigation of Development Infants With Primary Congenital Hypothyroidism

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Nigde Omer Halisdemir University · Academic / Other
• Sex: All
• Age: 6 Months – 18 Months
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Congenital Hypothyroidism

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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
BEHAVIORAL	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.

Timeline

• Start date: 2025-12-20
• Primary completion: 2026-12-15
• Completion: 2026-12-20
• First posted: 2025-12-12
• Last updated: 2026-02-12

Locations

1 site across 1 country: Turkey (Türkiye)