- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05217186
Associations Between Early Neonatal Neuroimaging, Hammersmith Infant Neurological Examination and General Movements (highrisk)
January 19, 2022 updated by: Hatice Adiguzel, Kahramanmaras Sutcu Imam University
Associations Between Early Neonatal Neuroimaging, Hammersmith Infant Neurological Examination and General Movements Assessment in a Cohort of High Risk of Infants: One Year Follow Up
High risk infant is defined as infant with a negative history of environmental and biological factors, which can lead to neuromotor development problems.
It is a heterogeneous group of premature infants born under thirty-seven weeks of age, with infants with low birth weight, term or developmental retardation for various reasons.
Therefore, preterm infants with low birth weight can survive with a neurological sequelae such as cerebral palsy (CP), epilepsy, hearing and vision loss, mental retardation, speech and speech problems, and learning difficulties.
The clinical diagnosis of CP, which can be observed in high-risk infants, is based on the combination of some neuroimaging and neurological examinations and assesments like neonatal imaging, general movements (GMs) and Hammersmith Infant Neurological Examination (HINE).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
High-risk infants may encounter many problems in terms of motor, cognitive, sensory, social, and academic development.
Premature and LBW infants are at higher risk in terms of motor and cognitive development problems.
Approximately 50% of these infants encounter neurodevelopmental problems.
These problems are related to gestational age (GA), birth weight, brain damage occurring during the prenatal/perinatal period, and medical risk factors.
Prematurity and low birth weight (LBW) are also among the most important causes of CP.
Three methods with the best predictable validity that can determine CP before the adjusted age of 5-month is Magnetic Resonance Imaging (MRI), Prechtl's Assessment of General Movements (GMs), Hammersmith Infant Neurological Evaluation (HINE).
In recent years, the diagnosis of high-risk of CP can be detected at 3 months with predictive validity and reliability by evaluating the quality of GMs.
GMs are now considered the gold standard for early detection of CP because of its high sensitivity and specificity than MRI, cranial US and neurological evaluations.
It was also found that cognitive or language skills may be inadequate in school age in patients with inadequate movement character and in the same postural patterns according to age, although GMs are normal.
So new clinical care guidelines and new intervention research for infants with CP under the age of 2, needs to be shown.
So this study aims to examine the associations between early neonatal neuroimaging, HINE and GMs assessment in a Cohort of High Risk of Infants with one year of follow up.
Study Type
Observational
Enrollment (Actual)
63
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
-
-
Dulkadiroglu
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Kahramanmaras, Dulkadiroglu, Turkey, 46100
- Hatice Adiguzel
-
-
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
5 months to 9 months (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
High risk of infants for cerebral palsy.
Description
Inclusion Criteria:
- Have periventricular hemorrhage, ICH stages 2, 3, 4, cystic PVL, stage 3 HIE, kernicterus, perinatal asphyxia, chronic lung disease, RDS, BPD, long-term oxygen (7 days), >24 hours mechanical ventilator (MV) support, 5th minute Apgar Score <3, neonatal sepsis, necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), gestation age <32 weeks, and prematurity due to preterm/multiple births<1500 gr.
Exclusion Criteria:
- Infants with congenital malformation (Spina Bifida, Congenital Muscular Torticollis, Arthrogriposis Multiplex Congenita etc.)
- Infants diagnosed with metabolic and genetic diseases (Down Syndrome,Spinal Muscular Atrophy, Duchenne Muscular Dystrophy etc.)
- Infants still intubated and mechanical ventilator dependent at postterm 3 months.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III)
Time Frame: Change from the baseline of the BAYLEY-III score at 3, 6,12th month of infants
|
The BSID-III is a neurocognitive assessment used to evaluate infants from 0-42 months and to monitor their development with 5 domains: cognitive, language (receptive and expressive communication), motor (fine and gross motor), social-emotional, and adaptive functions (17).
The first three domains will be assessed.
To allow comparison of results from the 5 domains, a composite score will be calculated for each domain (mean, 100±15).
A composite score below -2 standard deviation (SD) (<70) will be considered a severe delay for all domains.
|
Change from the baseline of the BAYLEY-III score at 3, 6,12th month of infants
|
Neonatal Magnetic Resonance Imaging (MRI)
Time Frame: at term age of infants (40 weeks), one assesment
|
Classification will be made according to the myelination status of the posterior internal capsule (PLIC), which is a robust marker showing the integrity of the cortical-spinal cord pathways at term.
|
at term age of infants (40 weeks), one assesment
|
Hammersmith Neonatal Neurological Examination (HNNE)
Time Frame: at term age of infants (40 weeks), one assesment
|
HNNE Developed by Dubowitz and used for clinical and research purposes in the neurological examination of infants.
The current form of the examination; Optimality scores were standardized by evaluating low-risk term and high-risk preterm infants at term age, 6-48 hours after birth.
This scale consists of a standard proforma consisting of 34 items.
Items in the proforma are scored between 1-3.
Half points can be given to an item.
High scores indicate good neurological status.
This proforma; It is divided into 6 categories: tone (10), tone patterns (5), reflexes (6), movements (3), abnormal signs (3), and behavior (7).
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at term age of infants (40 weeks), one assesment
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Hammersmith Infant Neurological Examination (HINE)
Time Frame: Change from the baseline of the HINE score at 2, 3, 6, 9,12th month of infants
|
The HINE is a simple, standardized, and scorable test for the clinical neurological evaluation of 2-to-24-month-old infants.
It has 3 sections: (1) neurological examination (26 items, scored) evaluating cranial nerve function, posture, movements, tone, reflexes, and reactions, (2) motor milestones (8 items, unscored), and (3) behaviour (3 items, unscored).
Each of the 26 items is scored first separately (as 0, 1, 2, or 3, half scores) and then the total score is calculated with a maximum score of 78.
Higher score indicates good neurological function.
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Change from the baseline of the HINE score at 2, 3, 6, 9,12th month of infants
|
General Movement Assessment (GMs)1
Time Frame: Measurement at preterm age (birth to 40weeks)
|
General movements (GMs) are the spontaneous movement repertoire present from early foetal life until 20 weeks post-term.
From birth to 8 post-term weeks, they have a "writhing" character.
They will be scored as cs-pr-n-ch.
N show normal movement patterns.
|
Measurement at preterm age (birth to 40weeks)
|
General Movement Assessment (GMs)2
Time Frame: Measurement between the term age to 9th weeks
|
General movements (GMs) are the spontaneous movement repertoire present from early foetal life until 20 weeks post-term.
From birth to 8 post-term weeks, they have a "writhing" character.
They will be scored as cs-pr-n-ch.
N show normal movement patterns.
|
Measurement between the term age to 9th weeks
|
General Movement Assessment (GMs)3
Time Frame: Measurement at fidgety periods of life (between 10th weeks to 20th weeks)
|
General movements (GMs) are the spontaneous movement repertoire present from early foetal life until 20 weeks post-term.
From birth to 8 post-term weeks, they have a "writhing" character and then till about 20 weeks a "fidgety" character.
Two specific abnormal movement patterns reliably predict CP in fidgety term: F (-): the absence of the fidgety character from 8-20 post-term weeks.
Fidgety movements (FMs) are classified as (a) normal (F+), (b) absent (AF), when normal FMs are never observed and (c) abnormal (F-).
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Measurement at fidgety periods of life (between 10th weeks to 20th weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
demographic information1
Time Frame: first day of birth
|
birth age in weeks
|
first day of birth
|
demographic information2
Time Frame: first day of birth
|
birth weight in kilograms
|
first day of birth
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
September 15, 2020
Primary Completion (ACTUAL)
September 30, 2021
Study Completion (ACTUAL)
October 15, 2021
Study Registration Dates
First Submitted
January 5, 2022
First Submitted That Met QC Criteria
January 19, 2022
First Posted (ACTUAL)
February 1, 2022
Study Record Updates
Last Update Posted (ACTUAL)
February 1, 2022
Last Update Submitted That Met QC Criteria
January 19, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KSU1
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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