Infants With Primary Congenital Hypothyroidism and Development

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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

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.

Study 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. 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

Primary outcome measure(s)

• Motor development — 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 — 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 — 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.

Trial sites (1)

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