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

NCT05749796 | Unknown

• 1 other identifier: GaziosmanpasaU_Erol_04
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant Development

Outcome Measures

Primary Outcomes (3)

• Object Permanence Scale

  The minimum score of the Object Permanence Scale is 0, and the maximum score is 10. Higher scores indicate better outcome.

  Baseline

• The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) motor and cognitive subscales

  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.

  Baseline

• Hammersmith infant neurological assessment

  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.

  Baseline

Eligibility Criteria

• Age: 7 Months - 16 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants aged 7-16 months with risk factors

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Faculty of Health Sciences, Tokat Gaziosmanpaşa University

Tokat Province, 60250, Turkey (Türkiye)

RECRUITING

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 19, 2023
• First Posted: March 1, 2023
• Study Start: March 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: May 31, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

TU (1)