Investigation of the Relationship Between Development, Neurological Assessment and Object Permanence in High Risk Infants.

Recruiting

• Conditions: Infant Development

• Registration Number: NCT05749796
• Lead Sponsor: Tokat Gaziosmanpasa University

Brief Summary

The aim of the study is to examine the relationship between development, neurological assessment and object permanence in risky infants aged 7-16 months. The sample of the study will consist of babies between 7-16 months at risk (preterm, low birth weight, asphyxia, hyperbillirubinemia, etc.). Inclusion criteria for the study: Between 7-16 months, having at least one risk factor. Exclusion criteria: Medical complications (eg, severe visual impairment) limiting participation in assessments; autism, down syndrome, or spinal cord injury; diagnosed uncontrolled seizure disorder; or a neurodegenerative disorder. Parents who agreed to participate in the study will be asked to fill out the demographic information questionnaire. Object permanence scale, Bayley III infant and toddler development scale and Hammersmith infant neurologic assessment will be applied to infants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-19
• Study First Submitted QC: 2023-02-19
• Study Start: 2023-03-01
• Study First Posted: 2023-03-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13
• Primary Completion: 2024-04-30
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Between 7-16 months, having at least one risk factor

Exclusion Criteria

• Medical complications (eg, severe visual impairment) limiting participation in assessments; autism, down syndrome, or spinal cord injury; diagnosed uncontrolled seizure disorder; or a neurodegenerative disorder

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Object Permanence Scale	Baseline	The minimum score of the Object Permanence Scale is 0, and the maximum score is 10. Higher scores indicate better outcome.
The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) motor and cognitive subscales	Baseline	Cognitive subscale consists of 91 items and Motor subscale consists of 138 items. Items are scored as 1 (done) and 0 not able to). Higher scores indicate better outcome.
Hammersmith infant neurological assessment	Baseline	Each item is individually scored from zero to three, and individual scores are summed to obtain a global optimality score. The overall score can range from a minimum of 0 to a maximum of 78 points.

Trial Locations

Locations (1)

Faculty of Health Sciences, Tokat Gaziosmanpaşa University; 🇹🇷 Tokat, Turkey