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Neurodevelopmental Assessment of Infants With Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT03577756
Recruitment Status : Recruiting
First Posted : July 4, 2018
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Akmer Mutlu, 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.

Condition or disease Intervention/treatment
Neurodevelopmental Disorders Cystic Fibrosis Other: Neurodevelopmental assessments

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Neurodevelopmental Assessment Outcomes of Infants With Cystic Fibrosis
Actual Study Start Date : August 6, 2018
Estimated Primary Completion Date : December 12, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.




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Ages Eligible for Study:   12 Months to 12 Months   (Child)
Sexes 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.
Criteria

Inclusion Criteria:

  • having diagnosis of cystic fibrosis
  • to be postterm12 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03577756


Contacts
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Contact: Akmer Mutlu, PhD +90-312-305-1576 akmermutlu@yahoo.com
Contact: Haluk Tekerlek, Bachelor +90-535-591-5009 haluktekerlek@gmail.com

Locations
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Turkey
Hacettepe University Recruiting
Ankara, Turkey, 06100
Contact: Akmer Mutlu, PhD    +90-312-305-1576 ext 201    akmermutlu@yahoo.com   
Contact: Haluk Tekerlek, Bachelor    +90-535-591-5009    haluktekerlek@gmail.com   
Sponsors and Collaborators
Hacettepe University

Publications:
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Responsible Party: Akmer Mutlu, Associate professor, Hacettepe University
ClinicalTrials.gov Identifier: NCT03577756     History of Changes
Other Study ID Numbers: earlyrehabcysticfibrosis
First Posted: July 4, 2018    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Akmer Mutlu, Hacettepe University:
cystic fibrosis
neurodevelopment
early rehabilitation
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Neurodevelopmental Disorders
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Mental Disorders