Development of a Scale for Evaluation of Neuromotor Development of Infants

Infant Development Clinical Trial

Official title:

Development of a Scale and Psychometric Test for Evaluation of Neuromotor Development of Infants in the Neonatal Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05860166
• Other study ID #: 2022/117
• Status: Completed
• Phase: N/A
• Start date: March 16, 2022
• Est. completion date: April 25, 2023

Study information

• Verified date: May 2023
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: April 25, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 1 Month

Eligibility

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.

Related Conditions & MeSH terms

• Infant Development
• Infant, Newborn, Diseases
• Motor Delay
• Neonatal Disease
• Neurodevelopmental Disorders
• Premature

Intervention

Other:
• Test Scale
Developing an Neurodevelopment Test for evaluating infants in their neonatal period.

Locations

Country	Name	City	State
Turkey	Nilay Çömük Balci	Samsun	Atakum

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal Infant Motor Assessment Scale	To reveal the applicability of the Neonatal Infant Motor Assessment Scale (NIMAS) test, which reveals the neurological and motor performance of infants hospitalized in the NICU.	through study completion, an average of 1 year
Secondary	Dubowitz Neurologocial Assessment	Neurodevelopmental Assessment of the infants in neonatal period.	through study completion, an average of 1 year
Secondary	Amiel-Tison Neurologocial Assessment	Neurodevelopmental Assessment of the infants in neonatal period.	through study completion, an average of 1 year