ASQ Scores of Transient Hypothyroxinemia of Prematurity

Neurodevelopmental Abnormality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05901623
• Other study ID #: 2022-20-05
• Status: Completed
• Start date: February 1, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: June 2023
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 1, 2023
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 1 Month

Eligibility

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

Related Conditions & MeSH terms

• Neurodevelopmental Abnormality
• Premature Birth
• Transient Hypothyroxinemia of Prematurity

Intervention

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

Locations

Country	Name	City	State
Turkey	Istanbul Kanuni Sultan Suleyman Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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