Infants With Primary Congenital Hypothyroidism and Development
NCT ID: NCT07280104
Last Updated: 2025-12-12
Study Results
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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ENROLLING_BY_INVITATION
40 participants
OBSERVATIONAL
2025-12-20
2026-12-20
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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congenital hypothyroidism
The thyroid gland is responsible for producing hormones necessary for normal growth and development. Congenital hypothyroidism is a condition characterized by an underactive or absent thyroid gland in infants.
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
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.
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.
Control Group
A control group of 20 healthy children, born at term and aged between 6 and 18 months, without primary congenital hypothyroidism will be created.
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
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.
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.
Interventions
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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
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Infants born at term.
* Between 6 and 18 months old.
Exclusion Criteria
* 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
6 Months
18 Months
ALL
Yes
Sponsors
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Nigde Omer Halisdemir University
OTHER
Responsible Party
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Rabia ZORLULAR
principal investigator
Locations
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Nigde Omer Halisdemir University
Niğde, , Turkey (Türkiye)
Countries
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References
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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.
Other Identifiers
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Congenital hypothyroidism
Identifier Type: -
Identifier Source: org_study_id
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