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Infants With Primary Congenital Hypothyroidism and Development

ConditionCongenital Hypothyroidism
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-18
SponsorNigde Omer Halisdemir University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Infants with secondary congenital hypothyroidism,

Preterm infants,

Those with congenital infections or proven genetic alterations,

Infants diagnosed with metabolic, neurological, or genetic diseases,

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • neurological status

    Behavioral

    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 functions

    Behavioral

    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 development

    Behavioral

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: congenital hypothyroidism3 interventions
Group B: Control Group3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
6-18 month
2

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.

Time frame
6-18 months
3

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.

Time frame
6-18 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nigde Omer Halisdemir University

Lead sponsor

Source ClinicalTrials.gov
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