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Development of a Scale for Evaluation of Neuromotor Development of Infants

Primary Purpose

Infant Development, Premature, Neurodevelopmental Disorders

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Test Scale
Sponsored by
Ondokuz Mayıs University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infant Development

Eligibility Criteria

1 Day - 1 Month (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nilay Çömük Balci

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

trial group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Dubowitz Neurologocial Assessment
Neurodevelopmental Assessment of the infants in neonatal period.
Amiel-Tison Neurologocial Assessment
Neurodevelopmental Assessment of the infants in neonatal period.

Full Information

First Posted
April 26, 2023
Last Updated
May 23, 2023
Sponsor
Ondokuz Mayıs University
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1. Study Identification

Unique Protocol Identification Number
NCT05860166
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 16, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
April 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ondokuz Mayıs University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Development, Premature, Neurodevelopmental Disorders, Neonatal Disease, Motor Delay

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
trial group
Arm Type
Experimental
Arm Description
The Clinical trial group consists of infants to whom the tests will be applied.
Intervention Type
Other
Intervention Name(s)
Test Scale
Intervention Description
Developing an Neurodevelopment Test for evaluating infants in their neonatal period.
Primary Outcome Measure Information:
Title
Neonatal Infant Motor Assessment Scale
Description
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.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Dubowitz Neurologocial Assessment
Description
Neurodevelopmental Assessment of the infants in neonatal period.
Time Frame
through study completion, an average of 1 year
Title
Amiel-Tison Neurologocial Assessment
Description
Neurodevelopmental Assessment of the infants in neonatal period.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nilay Comuk Balci
Organizational Affiliation
Ondokuz Mayıs University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nilay Çömük Balci
City
Samsun
State/Province
Atakum
ZIP/Postal Code
55139
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Development of a Scale for Evaluation of Neuromotor Development of Infants

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