Standardized Infant NeuroDevelopmental Assessment (SINDA) in 0-24 Months Age in Turkey

NCT ID: NCT04889027

Last Updated: 2023-04-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-17
• Study Completion Date: 2021-07-01

Brief Summary

This study aims to assess Turkish validity and reliability of Standardized Infant Neurodevelopmental Assessment and to spread its use for evaluation in early rehabilitation in our country.

Detailed Description

There are developments in the field of diagnosing children with a high risk of developmental disorders such as cerebral palsy (CP), mental problems and autism spectrum disorder in infancy. In particular, in infants experiencing the onset of extrauterine life in the neonatal intensive care unit, the combination of neonatal neuroimaging along with the assessment of general movements results in a highly accurate prediction of CP .

A clinical tool often used in predictions is a neurological examination. Various standard variants are available, such as the Hammersmith Infant Neurological Examination (HINE), Alberta Infant Motor Scale (AIMS).

The neurological scale of SINDA is designed as a screening tool as follows: (1) in the first year of life after the neonatal period, that is, in the corrected age range of 6 weeks to 12 months; (2) covers all infant neurological areas; (3) it is standardized, that is, it has a set of items and criteria identical to that age range; (4) results in a score that is largely independent of the baby's age; (5) general pediatricians are easy to use and take about 10 minutes to do (including recording scores); (6) contains a substantial part of items assessing the quality of spontaneous movements; and (7) helps predict developmental outcome .This study aims to assess Turkish validity and reliability of Standardized Infant Neurodevelopmental Assessment and to spread its use for evaluation in early rehabilitation in our country.

Conditions

Infant, Premature, Diseases; Motor Development

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Standardized Infant NeuroDevelopmental Assessment

The neurological scale of SINDA is designed as a screening tool as follows: (1) in the first year of life after the neonatal period, that is, in the corrected age range of 6 weeks to 12 months; (2) covers all infant neurological areas; (3) it is standardized, that is, it has a set of items and criteria identical to that age range; (4) results in a score that is largely independent of the baby's age; (5) general pediatricians are easy to use and take about 10 minutes to do (including recording scores); (6) contains a substantial part of items assessing the quality of spontaneous movements; and (7) helps predict developmental outcome (Hadder-Algra et al., 2018).

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Alberta Infant Motor Scale (AIMS); Hammersmith Infant Neurological Examination (HINE)

Eligibility Criteria

Inclusion Criteria

• at-risk infants
• discharged from neonatal intensive care unit;
• age between 0 - 24 months old (corrected age for premature infants);
• having a family acceptance for the participation

Exclusion Criteria

• having congenital anomalies,
• musculoskeletal disorders,
• cyanotic congenital heart disease and
• mechanical dependency

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

Nilay Comuk Balci

Pt, PhD, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

NILAY ÇÖMÜK BALCI

Role: PRINCIPAL_INVESTIGATOR

Ondokuz Mayıs University

Locations

Nilay Çömük Balci

Samsun, Atakum, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2020/017

Identifier Type: -

Identifier Source: org_study_id