Congenital HypothyroidismNCT07280104
Infants With Primary Congenital Hypothyroidism and Development
An observational study of Congenital Hypothyroidism, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Congenital Hypothyroidism
- What is being tested?
- neurological status, sensory processing functions and Motor development
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2025to 20 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Nigde Omer Halisdemir University
Niğde
Rabia ZORLULAR, +5424362082, rabiaeraslan118@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Congenital Hypothyroidism
- Being tested
- neurological status, sensory processing functions, Motor development
- Keywords
- Hypothyroidism, neurological status, motor development, sensory processing
- Medical subject headings
- Congenital Hypothyroidism, Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurological statusBehavioural
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.
sensory processing functionsBehavioural
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
Motor developmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: neurological status; Behavioral: sensory processing functions; Behavioral: Motor development | |
| 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. Receives: Behavioral: neurological status; Behavioral: sensory processing functions; Behavioral: Motor development |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. 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.
Measured: 6-18 month
Sensory development
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.
Measured: 6-18 months
Neurological Examination
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.
Measured: 6-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start20 Dec 2025
- Primary completion15 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital HypothyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia ZORLULAR, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280104
- Sponsor's protocol ID
- Congenital hypothyroidism
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Naafs JC, Marchal JP, Fliers E, Verkerk PH, Luijten MAJ, Boelen A, van Trotsenburg ASP, Zwaveling-Soonawala N. Cognitive and Motor Outcome in Patients with Early-Detected Central Congenital Hypothyroidism Compared with Siblings. J Clin Endocrinol Metab. 2021 Mar 8;106(3):e1231-e1239. doi: 10.1210/clinem/dgaa901.
PubMed 33274354
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Development Infants With Primary Congenital Hypothyroidism
- ClinicalTrials.gov ID
- NCT07280104
- Acronym / sponsor ID
- Congenital hypothyroidism
- Conditions
- Congenital Hypothyroidism
- Keywords
- Hypothyroidism, neurological status, motor development, sensory processing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| congenital hypothyroidism | – | Behavioral: neurological status, Behavioral: sensory processing functions, Behavioral: Motor developmentThe 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. |
| Control Group | – | Behavioral: neurological status, Behavioral: sensory processing functions, Behavioral: Motor developmentA control group of 20 healthy children, born at term and aged between 6 and 18 months, without primary congenital hypothyroidism will be created. |
Who may qualify
- Ages
- 6 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neurological statusThe 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. | Behavioural | Control Group, congenital hypothyroidism |
| sensory processing functionsThe 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 | Behavioural | Control Group, congenital hypothyroidism |
| Motor developmentThe 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. | Behavioural | Control Group, congenital hypothyroidism |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Background: PubMed 33274354Naafs JC, Marchal JP, Fliers E, Verkerk PH, Luijten MAJ, Boelen A, van Trotsenburg ASP, Zwaveling-Soonawala N. Cognitive and Motor Outcome in Patients with Early-Detected Central Congenital Hypothyroidism Compared with Siblings. J Clin Endocrinol Metab. 2021 Mar 8;106(3):e1231-e1239. doi: 10.1210/clinem/dgaa901.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Hypothyroidism, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rabia ZORLULAR (+5424362082, rabiaeraslan118@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor development (time frame: 6-18 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07280104, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.