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Completed

NCT Number: NCT04889027

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

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.

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Key information

Age range

1 month–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Nilay Çömük Balci

Samsun, Atakum, 55139, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: Alberta Infant Motor Scale (AIMS), Hammersmith Infant Neurological Examination (HINE)

Primary outcomes

  1. Standardized Infant NeuroDevelopmental Assessment

    Time frame: 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 outcomes

  1. Hammersmith Infant Neurological Examination (HINE)

    Time frame: 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).

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

Turkish Validity and Reliability of Standardized Infant NeuroDevelopmental Assessment

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 17, 2021
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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