Infants With Primary Congenital Hypothyroidism and Development

February 11, 2026 updated by: Rabia ZORLULAR, Nigde Omer Halisdemir University

Investigation of Development Infants With Primary Congenital Hypothyroidism

A review of the literature has focused primarily on the cognitive and motor development of children with congenital hypothyroidism, but no studies on sensory processing skills have been found. Considering the age range of the groups studied, studies conducted in the early stages of life are rare. This planned study aims to examine the neurological status, motor development, and sensory processing skills of infants aged 6-18 months, considering early synaptogenesis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The thyroid gland is responsible for producing the hormones necessary for normal growth and development. Congenital hypothyroidism is a condition characterized by underactive or absent thyroid gland in infants. Because thyroid hormone is essential for brain development, these children are at risk for brain damage and related cognitive and motor deficits. Initiating thyroxine supplementation early after birth through newborn screening programs aims to minimize this brain damage. Various studies on the effectiveness of these screening programs have shown that early thyroxine supplementation results in intelligence quotients within the normal range. However, mild cognitive and motor deficits, such as attention and balance problems, are present in most patients.

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.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Primary congenital hypothyroidism is an endocrine disorder that develops from birth due to insufficient thyroid hormone production by the thyroid gland. The term "primary" indicates that the problem originates directly from the thyroid gland itself, meaning there is no disorder at the hypothalamus or pituitary level. The study aims to recruit infants with and without primary congenital hypothyroidism (controls) who meet the inclusion criteria and whose parents provide voluntary consent.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Behavioral: 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.
Behavioral: 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
Behavioral: 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.
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.
Behavioral: 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.
Behavioral: 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
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor development
Time Frame: 6-18 month

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. Separate tests and rating scales are used to assess children's motor development, including both gross and fine motor skills. Each item in the PDMS-2 is scored on a 3-point ordinal scale reflecting the child's performance:

2 points - the child performs the item according to the specified criteria;

1 point - the child's performance shows emerging skill or partial success; 0 points - the child cannot or will not attempt the item, or the attempt does not meet criteria.
6-18 month
Sensory development
Time Frame: 6-18 months
The Test of Sensory Functions 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 months. It is used to determine whether an infant has a sensory processing problem and to what extent. It consists of 24 items. The TSFI requires the infant to be stimulated and interact with various materials. The total score ranges from 0-49, and the test has normative values for different age groups. Although it is used from the fourth month onward, the most reliable and valid results are obtained between 7-18 months.
6-18 months
Neurological Examination
Time Frame: 6-18 months
The Hammersmith Infant Neurological Examination (HINE) was planned to be used to assess the neurological status of infants. The HINE is a standardized examination for children aged 3 to 24 months, with high predictive value in the early detection of neurological disorders. It is a standardized clinical assessment tool developed to assess the neurological integrity, nervous system maturity, and potential neuromotor disorders in newborns. The HINE is grouped under three main subheadings: neurological, motor, and behavioral. Each item is scored from 0 to 3. The total score reflects the level of neurological maturity and abnormality. There are 26 items in total, with a maximum score of 78. A higher score indicates a more mature neurological status.
6-18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nigde Omer Halisdemir University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2025

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 20, 2026

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Actual)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Congenital hypothyroidism

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Congenital Hypothyroidism

Clinical Trials on neurological status

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe