Infant, Premature, DiseasesNCT04889027
Standardized Infant NeuroDevelopmental Assessment (SINDA) in 0-24 Months Age in Turkey
An observational study of Infant, Premature, Diseases and Motor Development, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to assess Turkish validity and reliability of Standardized Infant Neurodevelopmental Assessment and to spread its use for evaluation in early rehabilitation in our country. Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Infant, Premature, Diseases, Motor Development
- What is being tested?
- Standardized Infant NeuroDevelopmental Assessment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jul 2020to 1 Jul 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 1 month to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: At-risk infant between 0-24 months (adjusted age will be calculated for premature babies), who are followed as neurologically and developmentally, whose medical treatments have been completed and who are not in neonatal intensive care will be included in the study.
Who may be able to join
- at-risk infants
- discharged from neonatal intensive care unit;
- age between 0 - 24 months old (corrected age for premature infants);
- having a family acceptance for the participation
Who cannot join
- having congenital anomalies,
- musculoskeletal disorders,
- cyanotic congenital heart disease and
- mechanical dependency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Turkish Validity and Reliability of Standardized Infant NeuroDevelopmental Assessment
This study aims to assess Turkish validity and reliability of Standardized Infant Neurodevelopmental Assessment and to spread its use for evaluation in early rehabilitation in our country.
Read the detailed description
There are developments in the field of diagnosing children with a high risk of developmental disorders such as cerebral palsy (CP), mental problems and autism spectrum disorder in infancy. In particular, in infants experiencing the onset of extrauterine life in the neonatal intensive care unit, the combination of neonatal neuroimaging along with the assessment of general movements results in a highly accurate prediction of CP .
A clinical tool often used in predictions is a neurological examination. Various standard variants are available, such as the Hammersmith Infant Neurological Examination (HINE), Alberta Infant Motor Scale (AIMS).
The neurological scale of SINDA is designed as a screening tool as follows: (1) in the first year of life after the neonatal period, that is, in the corrected age range of 6 weeks to 12 months; (2) covers all infant neurological areas; (3) it is standardized, that is, it has a set of items and criteria identical to that age range; (4) results in a score that is largely independent of the baby's age; (5) general pediatricians are easy to use and take about 10 minutes to do (including recording scores); (6) contains a substantial part of items assessing the quality of spontaneous movements; and (7) helps predict developmental outcome .This study aims to assess Turkish validity and reliability of Standardized Infant Neurodevelopmental Assessment and to spread its use for evaluation in early rehabilitation in our country.
- Conditions
- Infant, Premature, Diseases, Motor Development
- Being tested
- Standardized Infant NeuroDevelopmental Assessment
- Keywords
- infant, validty, neurologic examination, motor development
- Medical subject headings
- Infant, Premature, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Infant NeuroDevelopmental AssessmentDiagnostic test
Also called Alberta Infant Motor Scale (AIMS), Hammersmith Infant Neurological Examination (HINE)
The neurological scale of SINDA is designed as a screening tool as follows: (1) in the first year of life after the neonatal period, that is, in the corrected age range of 6 weeks to 12 months; (2) covers all infant neurological areas; (3) it is standardized, that is, it has a set of items and criteria identical to that age range; (4) results in a score that is largely independent of the baby's age; (5) general pediatricians are easy to use and take about 10 minutes to do (including recording scores); (6) contains a substantial part of items assessing the quality of spontaneous movements; and (7) helps predict developmental outcome (Hadder-Algra et al., 2018).
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Infant NeuroDevelopmental Assessment
The neurological scale of SINDA is designed as a screening tool as follows: (1) in the first year of life after the neonatal period, that is, in the corrected age range of 6 weeks to 12 months; (2) covers all infant neurological areas; (3) it is standardized, that is, it has a set of items and criteria identical to that age range; (4) results in a score that is largely independent of the baby's age; (5) general pediatricians are easy to use and take about 10 minutes to do (including recording scores); (6) contains a substantial part of items assessing the quality of spontaneous movements; and (7) helps predict developmental outcome
Measured: 20-30 minutes
Secondary outcomes (2)
Hammersmith Infant Neurological Examination (HINE)
The HINE includes three sections, the Neurological Examination, the Development of Motor Functions and the State of Behaviour. The first section evaluates cranial nerve, posture, movements, tone and reflexes. These items are not age-dependent. The second section evaluates head control, sitting, voluntary grasping, rolling, crawling and walking. The third section evaluates state of consciousness, emotional state and social orientation.
Measured: 30-40 minutes
Alberta Infant Motor Scale (AIMS).
This scale is a norm-referenced observational tool designed for the evaluation of gross motor development in infants from birth to 18 months of age or the acquisition of independent walking. It consists of 58 items and four subscales: supine (9 items), prone (21 items), sitting (12 items) and standing (16 items), which are observed in postural alignment, antigravity movements and surface contact.
Measured: 30-45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start17 Jul 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Premature, DiseasesStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilay Comuk Balci, Ondokuz Mayıs University
- Investigators
- NILAY ÇÖMÜK BALCI, Principal investigator, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889027
- Sponsor's protocol ID
- 2020/017
- Status last verified
- Apr 2023
- First submitted
- 10 May 2021
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validity and Reliability of Standardized Infant NeuroDevelopmental Assessment
- ClinicalTrials.gov ID
- NCT04889027
- Acronym / sponsor ID
- 2020/017
- Conditions
- Infant, Premature, Diseases, Motor Development
- Keywords
- infant, validty, neurologic examination, motor development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 17 May 2021 (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.
This study aims to assess Turkish validity and reliability of Standardized Infant Neurodevelopmental Assessment and to spread its use for evaluation in early rehabilitation in our country.
Detailed description
There are developments in the field of diagnosing children with a high risk of developmental disorders such as cerebral palsy (CP), mental problems and autism spectrum disorder in infancy. In particular, in infants experiencing the onset of extrauterine life in the neonatal intensive care unit, the combination of neonatal neuroimaging along with the assessment of general movements results in a highly accurate prediction of CP .
A clinical tool often used in predictions is a neurological examination. Various standard variants are available, such as the Hammersmith Infant Neurological Examination (HINE), Alberta Infant Motor Scale (AIMS).
The neurological scale of SINDA is designed as a screening tool as follows: (1) in the first year of life after the neonatal period, that is, in the corrected age range of 6 weeks to 12 months; (2) covers all infant neurological areas; (3) it is standardized, that is, it has a set of items and criteria identical to that age range; (4) results in a score that is largely independent of the baby's age; (5) general pediatricians are easy to use and take about 10 minutes to do (including recording scores); (6) contains a substantial part of items assessing the quality of spontaneous movements; and (7) helps predict developmental outcome .This study aims to assess Turkish validity and reliability of Standardized Infant Neurodevelopmental Assessment and to spread its use for evaluation in early rehabilitation in our country.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- At-risk infant between 0-24 months (adjusted age will be calculated for premature babies), who are followed as neurologically and developmentally, whose medical treatments have been completed and who are not in neonatal intensive care will be included in the study.
Key inclusion criteria (4 listed)
- at-risk infants
- discharged from neonatal intensive care unit;
- age between 0 - 24 months old (corrected age for premature infants);
- having a family acceptance for the participation
Key exclusion criteria (4 listed)
- having congenital anomalies,
- musculoskeletal disorders,
- cyanotic congenital heart disease and
- mechanical dependency
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 |
|---|---|---|
| Standardized Infant NeuroDevelopmental AssessmentAlso: Alberta Infant Motor Scale (AIMS), Hammersmith Infant Neurological Examination (HINE)The neurological scale of SINDA is designed as a screening tool as follows: (1) in the first year of life after the neonatal period, that is, in the corrected age range of 6 weeks to 12 months; (2) covers all infant neurological areas; (3) it is standardized, that is, it has a set of items and criteria identical to that age range; (4) results in a score that is largely independent of the baby's age; (5) general pediatricians are easy to use and take about 10 minutes to do (including recording scores); (6) contains a substantial part of items assessing the quality of spontaneous movements; and (7) helps predict developmental outcome (Hadder-Algra et al., 2018). | Diagnostic test | – |
Primary outcome
Standardized Infant NeuroDevelopmental Assessment
Time frame: 20-30 minutes
The neurological scale of SINDA is designed as a screening tool as follows: (1) in the first year of life after the neonatal period, that is, in the corrected age range of 6 weeks to 12 months; (2) covers all infant neurological areas; (3) it is standardized, that is, it has a set of items and criteria identical to that age range; (4) results in a score that is largely independent of the baby's age; (5) general pediatricians are easy to use and take about 10 minutes to do (including recording scores); (6) contains a substantial part of items assessing the quality of spontaneous movements; and (7) helps predict developmental outcome
2 secondary outcomes
Hammersmith Infant Neurological Examination (HINE)
Time frame: 30-40 minutes
Alberta Infant Motor Scale (AIMS).
Time frame: 30-45 minutes
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 27 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Infant, Premature, Diseases
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
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.
NILAY ÇÖMÜK BALCI principal investigator
Ondokuz Mayıs University
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 Infant, Premature, Diseases and Motor Development, run by Ondokuz Mayıs 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 4 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 27 Apr 2023. 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?
Standardized Infant NeuroDevelopmental Assessment (time frame: 20-30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2023.