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Clinical Trials/NCT05901623
NCT05901623
Completed
Not Applicable

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

Kanuni Sultan Suleyman Training and Research Hospital1 site in 1 country70 target enrollmentFebruary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Transient Hypothyroxinemia of Prematurity
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Enrollment
70
Locations
1
Primary Endpoint
Long-term Neurodevelopment
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

• 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).

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
February 1, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Seda Yilmaz Semerci

Principal investigator

Kanuni Sultan Suleyman Training and Research Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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