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Clinical Trials/NCT05749796
NCT05749796
Recruiting
N/A

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

Tokat Gaziosmanpasa University1 site in 1 country32 target enrollmentMarch 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Infant Development
Sponsor
Tokat Gaziosmanpasa University
Enrollment
32
Locations
1
Primary Endpoint
Object Permanence Scale
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2023
End Date
May 31, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Tokat Gaziosmanpasa University
Responsible Party
Principal Investigator
Principal Investigator

Erkan Erol

Assistant Professor

Tokat Gaziosmanpasa University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Object Permanence Scale

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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