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Neurodevelopmental Assessment of Infants With Cystic Fibrosis

Neurodevelopmental Assessment Outcomes of Infants With Cystic Fibrosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03577756
Enrollment
24
Registered
2018-07-05
Start date
2018-06-11
Completion date
2021-03-01
Last updated
2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis, Neurodevelopmental Disorders

Keywords

cystic fibrosis, neurodevelopment, early rehabilitation

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.

Interventions

Infants' neurodevelopmental assessments will be done by the Bayley-III Baby and Child Development Assessment Scale (Bayley III) and the Gross Motor Function Measure. Bayley-III assess the development of five distinct scales to be consistent with areas of appropriate developmental assessment for children from birth to age 3. The Bayley-III revision includes Cognitive, Language, Motor, Social-Emotional, and Adaptive Behavior scales.The Gross Motor Function Measure (GMFM) has 5 dimensions: A-lying and roll- ing; B-sitting; C- kneeling and crawl- ing; D-standing; and E-walking, run- ning, and jumping. The items are scored from 0 to 3. All items are summarized and expressed as a value of total points for each dimension of the GMFM.

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
24 Months to 36 Months
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Gross motor function measure (GMFM) scoreabout 30 minutesIt 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 minutesThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026