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

Sponsor
Ondokuz Mayıs University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04889027
Collaborator
(none)
50
1
11.5
4.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Standardized Infant NeuroDevelopmental Assessment

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Turkish Validity and Reliability of Standardized Infant NeuroDevelopmental Assessment
Actual Study Start Date :
Jul 17, 2020
Anticipated Primary Completion Date :
Jul 1, 2021
Anticipated Study Completion Date :
Jul 1, 2021

Outcome Measures

Primary Outcome Measures

  1. Standardized Infant NeuroDevelopmental Assessment [20-30 minutes]

    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

Secondary Outcome Measures

  1. Hammersmith Infant Neurological Examination (HINE) [30-40 minutes]

    The HINE includes three sections, the Neurological Examination, the Development of Motor Functions and the State of Behaviour. The first section evaluates cranial nerve, posture, movements, tone and reflexes. These items are not age-dependent. The second section evaluates head control, sitting, voluntary grasping, rolling, crawling and walking. The third section evaluates state of consciousness, emotional state and social orientation.

  2. Alberta Infant Motor Scale (AIMS). [30-45 minutes]

    This scale is a norm-referenced observational tool designed for the evaluation of gross motor development in infants from birth to 18 months of age or the acquisition of independent walking. It consists of 58 items and four subscales: supine (9 items), prone (21 items), sitting (12 items) and standing (16 items), which are observed in postural alignment, antigravity movements and surface contact.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 24 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nilay Çömük Balci Samsun Atakum Turkey 55139

Sponsors and Collaborators

  • Ondokuz Mayıs University

Investigators

  • Principal Investigator: NILAY ÇÖMÜK BALCI, Ondokuz Mayıs University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nilay Comuk Balci, Pt, PhD, Associate Professor, Ondokuz Mayıs University
ClinicalTrials.gov Identifier:
NCT04889027
Other Study ID Numbers:
  • 2020/017
First Posted:
May 17, 2021
Last Update Posted:
May 17, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nilay Comuk Balci, Pt, PhD, Associate Professor, Ondokuz Mayıs University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2021