Neurodevelopmental Assessment of Infants With Cystic Fibrosis

Completed

• Conditions: Cystic Fibrosis; Neurodevelopmental Disorders
• Interventions: Other: Neurodevelopmental assessments

• Registration Number: NCT03577756
• Lead Sponsor: Hacettepe University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-11
• Study First Submitted: 2018-06-23
• Study First Submitted QC: 2018-06-23
• Study First Posted: 2018-07-05
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-09
• Last Update Posted: 2021-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy infants	Neurodevelopmental assessments	Twelve months healthy infants will be assessed by the Bayley-III Baby and Child Development Assessment Scale (Bayley III) and the Rough Motor Function Measure.
Infants with cystic fibrosis	Neurodevelopmental assessments	Twelve months infants with cystic fibrosis will be assessed by the Bayley-III Baby and Child Development Assessment Scale (Bayley III) and the Rough Motor Function Measure.

Primary Outcome Measures

Name	Time	Method
Gross motor function measure (GMFM) score	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)	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.

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey