Cognitive and Motor Outcome in Patients with Early-Detected Central Congenital Hypothyroidism Compared with Siblings.
Jolanda C Naafs, Jan Pieter Marchal, Eric Fliers...
https://pubmed.ncbi.nlm.nih.gov/33274354Actively Recruiting
Age: 6Months - 18Months
All Genders
Healthy Volunteers
ID07280104
Investigation of Development in Infants With Primary Congenital Hypothyroidism
Led by Nigde Omer Halisdemir University · Updated on 2026-02-12
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying infants aged 6 to 18 months with primary congenital hypothyroidism, a condition where the thyroid gland is underactive or absent. This condition can affect brain development, leading to cognitive and motor challenges despite early hormone treatment. The study aims to explore neurological status, motor skills, and sensory processing abilities during this critical early stage of brain development called synaptogenesis. The goal is to better understand how congenital hypothyroidism impacts these developmental areas to support early follow-up and intervention. The study compares infants diagnosed and treated for primary congenital hypothyroidism with a control group of healthy infants born at term. Assessments include the Hammersmith Infant Neurological Examination to evaluate neurological status, the Test of Sensory Function in Infants to assess sensory processing, and the Peabody Developmental Motor Scales-2 to measure motor development. These tests are standardized and designed for infants within the study's age range. Participants will undergo developmental and neurological evaluations between 6 and 18 months of age. Researchers will collect data on motor skills, sensory abilities, and neurological health through these assessments. The study may help establish scientific evidence for early monitoring and intervention programs. The total participation period aligns with the infants' ages from 6 to 18 months, focusing on early detection of developmental differences.
CONDITIONS
Brief Title
Infants With Primary Congenital Hypothyroidism and Development
Who Can Participate
Age: 6Months - 18Months
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Infants diagnosed with primary congenital hypothyroidism and treated since the newborn period
- Infants born at full term
- Infants aged between 6 and 18 months
You will not qualify if you...
- Infants with secondary congenital hypothyroidism
- Preterm infants
- Infants with congenital infections or confirmed genetic alterations
- Infants diagnosed with metabolic, neurological, or genetic diseases
- Infants whose parents did not volunteer for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - At ages 6 to 18 months
Participants undergo assessments to evaluate neurological status, sensory processing functions, and motor development.
1 to 2 visits depending on age
Long-term Monitoring
Duration - Up to 12 months follow-up after initial assessment
Participants are observed to understand development outcomes related to congenital hypothyroidism during early infancy.
Periodic visits depending on developmental assessments
Trial Site Locations
Total: 1 location
1
Nigde Omer Halisdemir University
Niğde, Turkey (Türkiye)
Actively Recruiting
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Research Team
R
Rabia ZORLULAR
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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