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

September 11, 2023 updated by: Erkan Erol, Tokat Gaziosmanpasa University
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Tokat, Turkey, 60250
        • Recruiting
        • Faculty of Health Sciences, Tokat Gaziosmanpaşa University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months to 1 year (Child)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Infants aged 7-16 months with risk factors

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tokat Gaziosmanpasa University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

February 19, 2023

First Submitted That Met QC Criteria

February 19, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • GaziosmanpasaU_Erol_04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infant Development

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe