Development of a Scale for Evaluation of Neuromotor Development of Infants

Sponsor
Ondokuz Mayıs University (Other)
Overall Status
Completed
CT.gov ID
NCT05860166
Collaborator
(none)
68
1
1
13.3
5.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Test Scale
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Development of a Scale and Psychometric Test for Evaluation of Neuromotor Development of Infants in the Neonatal Intensive Care Unit
Actual Study Start Date :
Mar 16, 2022
Actual Primary Completion Date :
Apr 1, 2023
Actual Study Completion Date :
Apr 25, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: trial group

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

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

Outcome Measures

Primary Outcome Measures

  1. Neonatal Infant Motor Assessment Scale [20 minutes]

    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.

Secondary Outcome Measures

  1. Dubowitz Neurologocial Assessment [10 minutes]

    Neurodevelopmental Assessment of the infants in neonatal period.

  2. Amiel-Tison Neurologocial Assessment [10 minutes]

    Neurodevelopmental Assessment of the infants in neonatal period.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Day to 1 Month
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nilay Çömük Balci Samsun Atakum Turkey 55139

Sponsors and Collaborators

  • Ondokuz Mayıs University

Investigators

  • Principal Investigator: Nilay Comuk Balci, Ondokuz Mayıs University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nilay Comuk Balci, Pt, Phd, Assoc. Prof., Ondokuz Mayıs University
ClinicalTrials.gov Identifier:
NCT05860166
Other Study ID Numbers:
  • 2022/117
First Posted:
May 16, 2023
Last Update Posted:
May 16, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 16, 2023