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Clinical Trials/NCT03577756
NCT03577756
Completed
Not Applicable

Neurodevelopmental Assessment Outcomes of Infants With Cystic Fibrosis

Hacettepe University1 site in 1 country24 target enrollmentJune 11, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neurodevelopmental Disorders
Sponsor
Hacettepe University
Enrollment
24
Locations
1
Primary Endpoint
Gross motor function measure (GMFM) score
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Infants included in the study will be divided into two groups as healthy infants and cystic fibrosis infants . Demographic, natal and postnatal information of the infants will be available from patient files. 12 months infants with cystic fibrosis and healthy infants will be assessed by the Bayley-III Baby and Child Development Assessment Scale (Bayley III) and the Gross Motor Function Measure. The assessment outcomes of healthy and cystic fibrosis infants will be compared.

Registry
clinicaltrials.gov
Start Date
June 11, 2018
End Date
March 1, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Akmer Mutlu

Associate professor

Hacettepe University

Eligibility Criteria

Inclusion Criteria

  • having diagnosis of cystic fibrosis
  • to be postterm24-36 months old

Exclusion Criteria

  • Having congenital anomalies,
  • Having an acute infection,
  • Risk of high or low neurological impairment due to perinatal stroke, perinatal asphyxia, intra / peri-ventricular hemorrhage (IVH / PVL), bronchopulmonary dysplasia,
  • The baby's family not reluctant to involved in study.

Outcomes

Primary Outcomes

Gross motor function measure (GMFM) score

Time Frame: about 30 minutes

It consists of a total of 88 items in the supine-posed position and during rotation, 17 items in sitting, 20 items in sitting, 14 items in crawling and kneeling, 13 items during standing, 24 items during walking-running-jumping. The child is scored according to the degree of achievement of gross motor functions in these materials. If the child can not initiate the activity 0 is given, can initiate independently 1 is given, can partially complete 2 is given, can independently complete 3 is given.

The Bayley Scales of Infant Development, Third Edition (BSID III)

Time Frame: about 30 minutes

The Bayley-III includes Cognitive, Language, Motor, Social-Emotional, and Adaptive Behavior scales. Cognitive. The Cognitive scale of the Bayley-III contains 91 items. Language. This subtest contains 48 items. The Expressive Communication subtest assesses the individual's ability to vocalize, name pictures and objects, and communicate with others. Motor. The Bayley-III Motor scale include Fine Motor and Gross Motor subtests. The Fine Motor subtest contains 66 items and is purported to measure skills associated with eye movements, perceptual-motor integration, motor planning, and motor speed. The Gross Motor subtest contains 72 items and is designed to measure movements of the limbs and torso. Social-Emotional. This scale include 35 items, which measure emotional development and related behaviors. Adaptive Behavior. Bayley-III include the Adaptive Behavior Assessment System-Second Edition as a measure of adaptive skills.

Study Sites (1)

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