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

Infant, Premature, Diseases Clinical Trial

Official title:

Turkish Validity and Reliability of Standardized Infant NeuroDevelopmental Assessment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04889027
• Other study ID #: 2020/017
• Status: Completed
• Start date: July 17, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: April 2023
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Infant, Premature, Diseases
• Motor Development

Intervention

Diagnostic Test:
• 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).

Locations

Country	Name	City	State
Turkey	Nilay Çömük Balci	Samsun	Atakum

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hammersmith Infant Neurological Examination (HINE)	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.	30-40 minutes
Secondary	Alberta Infant Motor Scale (AIMS).	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.	30-45 minutes