Neurodevelopmental DisordersNCT03577756
Neurodevelopmental Assessment of Infants With Cystic Fibrosis
An observational study of Neurodevelopmental Disorders and Cystic Fibrosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 24 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopmental Disorders, Cystic Fibrosis
- What is being tested?
- Neurodevelopmental assessments
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jun 2018to 1 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- having diagnosis of cystic fibrosis
- to be postterm24-36 months old
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Neurodevelopmental Disorders, Cystic Fibrosis
- Being tested
- Neurodevelopmental assessments
- Keywords
- cystic fibrosis, neurodevelopment, early rehabilitation
- Medical subject headings
- Neurodevelopmental Disorders, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurodevelopmental assessmentsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Neurodevelopmental assessments | |
| 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. Receives: Other: Neurodevelopmental assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: about 30 minutes
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.
Measured: about 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start11 Jun 2018
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akmer Mutlu, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577756
- Sponsor's protocol ID
- earlyrehabcysticfibrosis
- Status last verified
- Apr 2021
- First submitted
- 23 Jun 2018
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. doi: 10.7326/0003-4819-107-1-51.
PubMed 3592448de Almeida Thomazinho P, de Miranda Chaves CR, Passaro 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.
PubMed 21680118Singer 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. doi: 10.1542/peds.100.6.987.
PubMed 9374570Tekerlek H, Yardimci-Lokmanoglu BN, Inal-Ince D, Ozcelik U, Mutlu A. Developmental Functioning Outcomes in Infants With Cystic Fibrosis: A 24- to 36-Month Follow-Up Study. Phys Ther. 2022 Jun 3;102(6):pzac037. doi: 10.1093/ptj/pzac037.
PubMed 35385120
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurodevelopmental Assessment Outcomes of Infants With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03577756
- Acronym / sponsor ID
- earlyrehabcysticfibrosis
- Conditions
- Neurodevelopmental Disorders, Cystic Fibrosis
- Keywords
- cystic fibrosis, neurodevelopment, early rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 5 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infants with cystic fibrosis | – | Other: Neurodevelopmental assessmentsTwelve 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. |
| Healthy infants | – | Other: Neurodevelopmental assessmentsTwelve months healthy infants will be assessed by the Bayley-III Baby and Child Development Assessment Scale (Bayley III) and the Rough Motor Function Measure. |
Who may qualify
- Ages
- 24 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- having diagnosis of cystic fibrosis
- to be postterm24-36 months old
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurodevelopmental assessmentsInfants' 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. | Other | Healthy infants, Infants with cystic fibrosis |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- Background: PubMed 3592448Sitrin 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. doi: 10.7326/0003-4819-107-1-51.
- Background: PubMed 21680118de Almeida Thomazinho P, de Miranda Chaves CR, Passaro 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.
- Background: PubMed 9374570Singer 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. doi: 10.1542/peds.100.6.987.
- Derived from this study: PubMed 35385120Tekerlek H, Yardimci-Lokmanoglu BN, Inal-Ince D, Ozcelik U, Mutlu A. Developmental Functioning Outcomes in Infants With Cystic Fibrosis: A 24- to 36-Month Follow-Up Study. Phys Ther. 2022 Jun 3;102(6):pzac037. doi: 10.1093/ptj/pzac037.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodevelopmental Disorders and Cystic Fibrosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross motor function measure (GMFM) score (time frame: about 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03577756, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.