Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-27 @ 5:39 AM
Study NCT ID:
NCT05860166
Status:
COMPLETED
Last Update Posted:
2023-05-25
First Post:
2023-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of a Scale for Evaluation of Neuromotor Development of Infants
Sponsor:
Ondokuz Mayıs University
Organization:
Study Overview
Official Title:
Development of a Scale and Psychometric Test for Evaluation of Neuromotor Development of Infants in the Neonatal Intensive Care Unit
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Although the scales used so far provide information about the neuromotor progression of a single baby, it is thought that they are not sufficient to distinguish babies from each other, and it is thought that there is no assessment battery that will adapt to the knowledge in their conditions and the functional development of babies. Therefore, the aim of our study is to reveal the applicability and psychometric properties of the Neonatal Infant Motor Assessment Scale (NIMAS) test, which reveals the neurological and motor performance of infants hospitalized in the NICU, both as automatic responses and functional behavior.
Detailed Description:
Evaluations in the neonatal period become extremely important in terms of early diagnosis, medical follow-up, and planning of necessary interventions. Considering the sensitive and unstable physiological conditions of term and preterm babies who need neonatal intensive care, the tests to be used in the evaluation should be of valid, reliable, and easily applicable standards. There are various neuromotor and neurobehavioral scales according to the purpose of use in the evaluation of the baby. These scales are used to detect disorders of the infant's central nervous system function, examine the relationship between neuromotor and behavioral functions, determine the risk of complications that may be encountered in the future, monitor the infant's development, and determine the effectiveness of the interventions. While rating scales focus on examining all aspects of behavioral performance, they provide a comprehensive assessment of higher neurological functions. These scales are used in the follow-up of premature babies receiving care in the neonatal intensive care unit and to determine the differences that may occur in their neurobehavioral development. It is stated that more specific neurological examinations are required for the diagnosis of neurodevelopmental problems that the premature baby may encounter in the long term or the evaluation of general movements (GMs) provides better predictive value. In addition, the fact that premature babies continue to mature by compensating for the deficiencies in the newborn period thanks to their high neuroplasticity ability makes it difficult to predict the neurobehavioral status of premature babies precisely. Although the scales used so far give information about the neuromotor progression of a single baby, it is thought that they are not sufficient to distinguish babies from each other. Today, it is thought that no evaluation battery will adapt to the knowledge of their conditions and the functional development of babies. Therefore, our study aims to reveal the applicability and psychometric properties of the Neonatal Infant Motor Assessment Scale (NIMAS) test, which reveals the neurological and motor performance of infants hospitalized in the NICU, both as automatic responses and functional behavior.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: