Clinical trial NCT05860166: Development of a Scale for Evaluation of Neuromotor Development of Infants
Official title: Development of a Scale and Psychometric Test for Evaluation of Neuromotor Development of Infants in the Neonatal Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Development
Premature
Neurodevelopmental Disorders
Neonatal Disease
Motor Delay
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 68
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* Born between 24-42 weeks of gestational age,
* The baby's vital signs are stable on the day of the test.

Exclusion Criteria:

* To undergo surgery,
* to be in the early post-op period \<7 days (the day of the tests),
* Receiving treatment for sepsis or intensive phototherapy,
* The baby is intubated and on a mechanical ventilator,
* Unstable vital signs and taking sedative drugs,
* Having a genetic syndrome,
* Having other medical conditions that may affect physiotherapy practice, such as multiple congenital anomalies, tracheoesophageal fistula, diaphragmatic hernia, congenital heart malformation, and/or necrotizing enterocolitis.

Primary outcomes:
measure: Neonatal Infant Motor Assessment Scale
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Dubowitz Neurologocial Assessment
timeFrame: through study completion, an average of 1 year
measure: Amiel-Tison Neurologocial Assessment
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Nilay Çömük Balci
state: Atakum
Study officials:
affiliation: Ondokuz Mayıs University
name: Nilay Comuk Balci
role: PRINCIPAL_INVESTIGATOR
References: