Clinical trial Recruiting at 1 site Observational Ages 6 Months to 18 Months

How congenital hypothyroidism affects development in infants

Official title: Investigation of Development Infants With Primary Congenital Hypothyroidism

Run by Nigde Omer Halisdemir University · NCT07280104 · Data updated 2026-11-12

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 typeObservational
Ages6 Months to 18 Months
SexAll
Enrollment40 (estimated)
SponsorNigde Omer Halisdemir University
Academic / other
Locations1 site (Niğde)
StatusRecruiting
StartedDecember 20, 2025
Main results expectedDecember 15, 2026
Study endsDecember 20, 2026
Registry record updatedFebruary 12, 2026
Trial IDNCT07280104 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Nigde Omer Halisdemir University
    Niğde, Turkey (Türkiye)
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.