Neurodevelopmental Assessment of Infants With Cystic Fibrosis

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.

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Key information

Conditions

Neurodevelopmental Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Mental Disorders Pancreatic Diseases Respiratory Tract Diseases

Age range

24 month–36 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neurodevelopmental assessments

Other

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.

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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Neurodevelopmental Assessment Outcomes of Infants With Cystic Fibrosis

Important dates

Study start: 2018
Primary completion: 2021
Study completion: 2021
First posted: Jul 5, 2018
Registry last updated: Apr 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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