Development of a Scale for Evaluation of Neuromotor Development of Infants

NCT05860166 | Completed

• 1 other identifier: 2022/117
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Dubowitz Neurologocial Assessment

  through study completion, an average of 1 year

• Amiel-Tison Neurologocial Assessment

  through study completion, an average of 1 year

Study Arms (1)

trial group

EXPERIMENTAL

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

Other: Test Scale

Interventions

Test Scale OTHER

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

trial group

Eligibility Criteria

• Age: 1 Day - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Nilay Çömük Balci

Samsun, Atakum, 55139, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth; Neurodevelopmental Disorders; Infant, Newborn, Diseases; Psychomotor Disorders

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mental Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Nilay Comuk Balci

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pt, Phd, Assoc. Prof.

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 16, 2023
• Study Start: March 16, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 25, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)