Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-24 @ 9:06 PM
Study NCT ID:
NCT07280104
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-12
First Post:
2025-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Infants With Primary Congenital Hypothyroidism and Development
Sponsor:
Nigde Omer Halisdemir University
Organization:
Study Overview
Official Title:
Investigation of Development Infants With Primary Congenital Hypothyroidism
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: