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 type | Observational |
|---|---|
| Ages | 6 Months to 18 Months |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Nigde Omer Halisdemir University Academic / other |
| Locations | 1 site (Niğde) |
| Status | Recruiting |
| Started | December 20, 2025 |
| Main results expected | December 15, 2026 |
| Study ends | December 20, 2026 |
| Registry record updated | February 12, 2026 |
| Trial ID | NCT07280104 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
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Nigde Omer Halisdemir University
Niğde, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Rabia ZORLULAR
- Email: rabiaeraslan118@gmail.com
- Phone: +5424362082
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Understanding brain development in congenital hypothyroidism: comparing affected children, healthy controls, and mild thyroid conditions
This study tests how brain development in children with congenital hypothyroidism compares to similar children without the condition and to kids with a mild thyroid finding.
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Thyroid size in healthy, full-term newborns
This study tests whether thyroid volume measured by ultrasound in healthy full-term newborns in Italy falls within expected ranges.
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OptiThyDose for children with congenital hypothyroidism and Graves' disease
This trial will test whether the OptiThyDose math model helps doctors choose the right thyroid medicine dose for newborns with congenital hypothyroidism and children with Graves' disease.
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Exploring genetic causes of congenital hypothyroidism
This study looks at the genetic causes of congenital hypothyroidism in babies born in Emilia-Romagna, Italy, to see how different genes might affect their condition and future health.
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Comparing different levothyroxine formulations for treating congenital hypothyroidism in newborns
This study is testing which of three different forms of levothyroxine—oral solution, liquid drops, or tablets—works best and is safest for newborns with congenital hypothyroidism.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.