How congenital hypothyroidism affects development in infants
Investigation of Development Infants With Primary Congenital Hypothyroidism
This project will test neurological status, motor skills, and sensory processing in babies aged 6–18 months who were treated for primary congenital hypothyroidism from birth.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 6 Months to 18 Months |
| Sex | All |
| Sponsor | Nigde Omer Halisdemir University Academic / other |
| Locations | 1 site (Niğde) |
| Trial ID | NCT07280104 on ClinicalTrials.gov |
What this trial studies
This single-center observational study will examine neurological status, motor development, and sensory processing in term infants aged 6–18 months who were diagnosed with primary congenital hypothyroidism and treated from the newborn period. Participants will undergo standardized neurological and developmental examinations and structured measures of sensory processing, with results compared to age-based norms. The work is motivated by early synaptogenesis and a gap in the literature on sensory processing in this age range, complementing prior work on cognition and motor outcomes. Findings are expected to inform timelines for early follow-up and possible interventions.
Who should consider this trial
Good fit: Term-born infants aged 6–18 months with primary congenital hypothyroidism who have been treated since the newborn period and are currently on therapy are ideal candidates.
Not a fit: Preterm infants, those with secondary hypothyroidism, congenital infections, proven genetic alterations, other metabolic/neurological/genetic diseases, or whose parents do not consent are excluded and would not benefit from participation.
Why it matters
Potential benefit: If successful, the results could help clinicians detect early sensory or motor differences and guide targeted follow-up and early intervention for infants with congenital hypothyroidism.
How similar studies have performed: Previous research shows early thyroxine treatment generally normalizes IQ but mild motor and attention problems can persist, while sensory processing in early infancy remains largely unstudied, making this a relatively novel area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Where this trial is running
Niğde
- Nigde Omer Halisdemir University — Niğde, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Rabia ZORLULAR
- Email: rabiaeraslan118@gmail.com
- Phone: +5424362082
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.