Neurodevelopmental Assessment of Infants With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Neurodevelopmental Assessment Outcomes of Infants With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03577756
• Other study ID #: earlyrehabcysticfibrosis
• Status: Completed
• Start date: June 11, 2018
• Est. completion date: March 1, 2021

Study information

• Verified date: April 2021
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Months to 36 Months

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Neurodevelopmental Disorders

Intervention

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.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

de Almeida Thomazinho P, de Miranda Chaves CR, Pássaro CP, Meio MD. Motor delay in cystic fibrosis infants: an observational study. Early Hum Dev. 2011 Dec;87(12):769-73. doi: 10.1016/j.earlhumdev.2011.05.012. Epub 2011 Jun 15. — View Citation

Singer L, Yamashita T, Lilien L, Collin M, Baley J. A longitudinal study of developmental outcome of infants with bronchopulmonary dysplasia and very low birth weight. Pediatrics. 1997 Dec;100(6):987-93. — View Citation

Sitrin MD, Lieberman F, Jensen WE, Noronha A, Milburn C, Addington W. Vitamin E deficiency and neurologic disease in adults with cystic fibrosis. Ann Intern Med. 1987 Jul;107(1):51-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gross motor function measure (GMFM) score	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
Primary	The Bayley Scales of Infant Development, Third Edition (BSID III)	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