Clinical trial NCT04889027: Standardized Infant NeuroDevelopmental Assessment (SINDA) in 0-24 Months Age in Turkey
Official title: Turkish Validity and Reliability of Standardized Infant NeuroDevelopmental Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Premature, Diseases
Motor Development
Keywords: infant
validty
neurologic examination
motor development
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Standardized Infant NeuroDevelopmental Assessment
timeFrame: 20-30 minutes
Secondary outcomes:
measure: Hammersmith Infant Neurological Examination (HINE)
timeFrame: 30-40 minutes
measure: Alberta Infant Motor Scale (AIMS).
timeFrame: 30-45 minutes
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Nilay Çömük Balci
state: Atakum
Study officials:
affiliation: Ondokuz Mayıs University
name: NILAY ÇÖMÜK BALCI
role: PRINCIPAL_INVESTIGATOR
References: