ASQ Scores of Transient Hypothyroxinemia of Prematurity

NCT05901623 | Completed

• 1 other identifier: 2022-20-05
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Transient Hypothyroxinemia of Prematurity; Neurodevelopmental Abnormality

Outcome Measures

Primary Outcomes (1)

• Long-term Neurodevelopment

  '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

Study Arms (2)

Case

Infants with THoP

Other: 'Ages and Stages Questionnaries' (ASQ)

Control

Healthy infants

Other: 'Ages and Stages Questionnaries' (ASQ)

Interventions

'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

Also known as: 'Ages and Stages Questionnaries: Social-Emotional' (ASQ:SE) Inventories

Case; Control

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Istanbul Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, 34303, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Glycation End Products, Advanced; Equipment and Supplies

Intervention Hierarchy (Ancestors)

Glycoconjugates; Carbohydrates; Toxins, Biological; Biological Factors

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 13, 2023
• Study Start: February 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: February 1, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)