ASQ Scores of Transient Hypothyroxinemia of Prematurity

June 12, 2023 updated by: Seda Yilmaz Semerci, Kanuni Sultan Suleyman Training and Research Hospital

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

• 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34303
        • Istanbul Kanuni Sultan Süleyman Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This study included newborn infants born at 28-36 gestational weeks, with a diagnosis of transient hypothyroxinemia of prematurity, and hospitalized in the neonatal intensive care unit. Healthy age-matched infants were included in the control group.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

February 1, 2023

Study Registration Dates

First Submitted

June 5, 2023

First Submitted That Met QC Criteria

June 5, 2023

First Posted (Actual)

June 13, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-20-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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