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Completed

NCT Number: NCT05901623

ASQ Scores of Transient Hypothyroxinemia of Prematurity

• Transient hypothyroxinemia of prematurity (THoP) is defined as free thyroxine (FT4) level is below the reference values despite normal TSH level in preterm infant. This study aims to evaluate the neurological development of infants with transient premature hypothyroxinemia (THoP).

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Key information

Conditions

Transient Hypothyroxinemia of Prematurity Neurodevelopmental Abnormality

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, 34303, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • newborn infants who were born at 28-36 gestational weeks
  • Infants who were hospitalized in the neonatal intensive care unit
  • Infants with transient hypothyroxinemia of prematurity

Exclusion criteria

  • Newborns with maternal thyroid disease,
  • Severe intracranial issues,
  • Chromosomal and congenital anomalies,
  • Infants older than 36 gestational weeks

Treatment and study plan

'Ages and Stages Questionnaries' (ASQ)

Other

''ASQ' is a screening tool for assessing the development of infants and preschoolers in the areas of communication, fine motor, gross motor, problem-solving and personal-social development, and 'ASQ:SE' is a screening tool for social-emotional development

Other names: 'Ages and Stages Questionnaries: Social-Emotional' (ASQ:SE) Inventories

Primary outcomes

  1. Long-term Neurodevelopment

    Time frame: 5 years

    'Ages And Stages Questionnaires' (ASQ) 'Ages And Stages Questionnaires: Social-Emotional' (ASQ:SE) Developmental Screening Tests evaluates the areas of communication, fine motor, gross motor, problem-solving and personal-social development. ASQ score differs 0-60 and results are interpreted in three group according to the gained points as normal, risky, and follow-up required.

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Official study title

Neurodevelopmental Outcome of the Infants With Transient Hypothyroxinemia of Prematurity in Newborn Intensive Care Unit

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 13, 2023
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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