Neurodevelopmental Assessment of Infants With Cystic Fibrosis

April 9, 2021 updated by: Akmer Mutlu, Hacettepe University

Neurodevelopmental Assessment Outcomes 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 3 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Infants with cystic fibrosis will be provided from the Hacettepe University Faculty of Medicine, Pediatric Chest Diseases Clinic and healthy infants will be provided from the Hacettepe University Department of Physiotherapy and Rehabilitation Developmental and Early Physiotherapy Unit.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Infants with cystic fibrosis
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.
Other: Neurodevelopmental assessments
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.
Healthy infants
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.
Other: Neurodevelopmental assessments
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
about 30 minutes
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.
about 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 11, 2018

Primary Completion (ACTUAL)

March 1, 2021

Study Completion (ACTUAL)

March 1, 2021

Study Registration Dates

First Submitted

June 23, 2018

First Submitted That Met QC Criteria

June 23, 2018

First Posted (ACTUAL)

July 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 12, 2021

Last Update Submitted That Met QC Criteria

April 9, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • earlyrehabcysticfibrosis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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