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ASQ Scores of Transient Hypothyroxinemia of Prematurity

Sponsor
Kanuni Sultan Suleyman Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05901623
Collaborator
(none)
70
Enrollment
1
Location
24
Actual Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: 'Ages and Stages Questionnaries' (ASQ)

Study Design

Study Type:
Observational
Actual Enrollment :
70 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Neurodevelopmental Outcome of the Infants With Transient Hypothyroxinemia of Prematurity in Newborn Intensive Care Unit
Actual Study Start Date :
Feb 1, 2021
Actual Primary Completion Date :
Mar 1, 2022
Actual Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Case

Infants with THoP

Other: 'Ages and Stages Questionnaries' (ASQ)
''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

    		•
    Control

    Healthy infants

    Other: 'Ages and Stages Questionnaries' (ASQ)
    ''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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Long-term Neurodevelopment [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 1 Month
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istanbul Kanuni Sultan Suleyman Training and Research Hospital Istanbul Turkey 34303

    Sponsors and Collaborators

    • Kanuni Sultan Suleyman Training and Research Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seda Yilmaz Semerci, Principal investigator, Kanuni Sultan Suleyman Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT05901623
    Other Study ID Numbers:
    • 2022-20-05
    First Posted:
    Jun 13, 2023
    Last Update Posted:
    Jun 15, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Premature Birth

    Study Results

    No Results Posted as of Jun 15, 2023