Development of a Scale for Evaluation of Neuromotor Development of Infants

NCT ID: NCT05860166

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-16
• Study Completion Date: 2023-04-25

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.

Conditions

Infant Development; Premature; Neurodevelopmental Disorders; Neonatal Disease; Motor Delay

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

trial group

The Clinical trial group consists of infants to whom the tests will be applied.

Group Type: EXPERIMENTAL

Test Scale

Intervention Type: OTHER

Developing an Neurodevelopment Test for evaluating infants in their neonatal period.

Interventions

Test Scale

Developing an Neurodevelopment Test for evaluating infants in their neonatal period.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

Nilay Comuk Balci

Pt, Phd, Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nilay Comuk Balci

Role: PRINCIPAL_INVESTIGATOR

Ondokuz Mayıs University

Locations

Nilay Çömük Balci

Samsun, Atakum, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2022/117

Identifier Type: -

Identifier Source: org_study_id