ASQ Scores of Transient Hypothyroxinemia of Prematurity

Completed

• Conditions: Neurodevelopmental Abnormality; Transient Hypothyroxinemia of Prematurity
• Interventions: Other: 'Ages and Stages Questionnaries' (ASQ)

• Registration Number: NCT05901623
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Primary Completion: 2022-03-01
• Study Completion: 2023-02-01
• Status Verified: 2023-06
• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-06-05
• Last Update Submitted: 2023-06-12
• Study First Posted: 2023-06-13
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	'Ages and Stages Questionnaries' (ASQ)	Healthy infants
Case	'Ages and Stages Questionnaries' (ASQ)	Infants with THoP

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Istanbul Kanuni Sultan Suleyman Training and Research Hospital; 🇹🇷 Istanbul, Turkey