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

NCT04889027 | Completed

• 1 other identifier: 2020/017
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Premature, Diseases; Motor Development

Keywords

infant; validty; neurologic examination; motor development

Outcome Measures

Primary Outcomes (1)

• 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

  20-30 minutes

Secondary Outcomes (2)

• Hammersmith Infant Neurological Examination (HINE)

  30-40 minutes

• Alberta Infant Motor Scale (AIMS).

  30-45 minutes

Interventions

Standardized Infant NeuroDevelopmental Assessment DIAGNOSTIC_TEST

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).

Also known as: Alberta Infant Motor Scale (AIMS), Hammersmith Infant Neurological Examination (HINE)

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

At-risk infant between 0-24 months (adjusted age will be calculated for premature babies), who are followed as neurologically and developmentally, whose medical treatments have been completed and who are not in neonatal intensive care will be included in the study.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Nilay Çömük Balci

Samsun, Atakum, 55139, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infant, Premature, Diseases

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• NILAY ÇÖMÜK BALCI

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pt, PhD, Associate Professor

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 17, 2021
• Study Start: July 17, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)