Cerebral PalsyhighriskNCT05217186
Associations Between Early Neonatal Neuroimaging, Hammersmith Infant Neurological Examination and General Movements
An observational study of Cerebral Palsy and Infant, Premature, Diseases, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 25 to 42 weeks
- Conditions the study is for
- Cerebral Palsy, Infant, Premature, Diseases, Infant Development
- What is being tested?
- Measurements
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2020to 15 Oct 2021
- How long will I take part?
- 1 Year
- 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 25 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Study population: High risk of infants for cerebral palsy.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hatice Adiguzel
Kahramanmaraş, Dulkadiroglu, 46100
About this study
Official title: 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).
Read the 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.
- Conditions
- Cerebral Palsy, Infant, Premature, Diseases, Infant Development, Neurologic Disorder, Development Delay, Infant Asphyxia
- Being tested
- Measurements
- Keywords
- Neonatal Neuroimaging, Hammersmith Infant Neurological Evaluation (HINE), General Movements (GMs), High Risk of Infants
- Medical subject headings
- Cerebral Palsy, Infant, Premature, Diseases, Nervous System Diseases, Learning Disabilities, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeasurementsDiagnostic test
Also called Measurements of neurological development.
All infants wirth high risk of cp will be assessed by neuroimaging and Hammersmith Neonatal Neurological Examination (HNNE) at term age, Prechtl's General movements (GMs) assessments form birth up to 3-5 months, and will be assesed by Hammersmith Infant Neurological Examination (HINE) at 2,3,6,9 and 12th months, also BAYLEY-III Infant and Toddler Development Assessment Scale (BAYLEY-III) at the 3rd, 6th, and 12th months.
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Magnetic Resonance Imaging (MRI)
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.
- CP development is unlikely. Minor anomalies not associated with normal imaging or development of CP, such as IVH grade 1-2. PLIC is in normal view.
- Uncertain, SP possible but unlikely. Images show some evidence of damage, but symmetrical myelination is present in PLICs. Examples are stage 3 IVH, stroke not affecting the motor pathway, or HIE followed by lesion without basal ganglia or thalamus (BGT), hypoxic-ischemic injury without PLIC, pyramids, or perirolandic area
- He is very likely to develop CP. Evidence of brain damage or malformations involving abnormal motor structures/absence of myelination in PLICs. Typical examples; stage IV IVH, cystic PVL, HIE with IGT involvement, or brain malformation with motor cortex involvement and any imaging abnormal and with PLIC
Measured: at term age of infants (40 weeks), one assesment
Hammersmith Neonatal Neurological Examination (HNNE)
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).
Measured: at term age of infants (40 weeks), one assesment
Hammersmith Infant Neurological Examination (HINE)
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.
Measured: Change from the baseline of the HINE score at 2, 3, 6, 9,12th month of infants
The Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III)
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.
Measured: Change from the baseline of the BAYLEY-III score at 3, 6,12th month of infants
General Movement Assessment (GMs)1
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.
Measured: Measurement at preterm age (birth to 40weeks)
General Movement Assessment (GMs)2
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.
Measured: Measurement between the term age to 9th weeks
General Movement Assessment (GMs)3
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-).
Measured: Measurement at fidgety periods of life (between 10th weeks to 20th weeks)
Secondary outcomes (2)
demographic information1
birth age in weeks
Measured: first day of birth
demographic information2
birth weight in kilograms
Measured: first day of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start15 Sep 2020
- Primary completion30 Sep 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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
- 63 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Adiguzel, Kahramanmaras Sutcu Imam University
- Investigators
- hatice adıgüzel, PhD, Principal investigator, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217186
- Sponsor's protocol ID
- KSU1
- Acronym
- highrisk
- Status last verified
- Jan 2022
- First submitted
- 5 Jan 2022
- Last updated
- 1 Feb 2022
- 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 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05217186
- Acronym / sponsor ID
- highrisk / KSU1
- Conditions
- Cerebral Palsy, Infant, Premature, Diseases, Infant Development, Neurologic Disorder, Development Delay, Infant Asphyxia
- Keywords
- Neonatal Neuroimaging, Hammersmith Infant Neurological Evaluation (HINE), General Movements (GMs), High Risk of Infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 1 Feb 2022 (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.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 25 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- High risk of infants for cerebral palsy.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| MeasurementsAlso: Measurements of neurological development.All infants wirth high risk of cp will be assessed by neuroimaging and Hammersmith Neonatal Neurological Examination (HNNE) at term age, Prechtl's General movements (GMs) assessments form birth up to 3-5 months, and will be assesed by Hammersmith Infant Neurological Examination (HINE) at 2,3,6,9 and 12th months, also BAYLEY-III Infant and Toddler Development Assessment Scale (BAYLEY-III) at the 3rd, 6th, and 12th months. | Diagnostic test | – |
Primary outcome
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. 1. CP development is unlikely. Minor anomalies not associated with normal imaging or development of CP, such as IVH grade 1-2. PLIC is in normal view. 2. Uncertain, SP possible but unlikely. Images show some evidence of damage, but symmetrical myelination is present in PLICs. Examples are stage 3 IVH, stroke not affecting the motor pathway, or HIE followed by lesion without basal ganglia or thalamus (BGT), hypoxic-ischemic injury without PLIC, pyramids, or perirolandic area 3. He is very likely to develop CP. Evidence of brain damage or malformations involving abnormal motor structures/absence of myelination in PLICs. Typical examples; stage IV IVH, cystic PVL, HIE with IGT involvement, or brain malformation with motor cortex involvement and any imaging abnormal and with PLIC
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).
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.
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.
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.
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.
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-).
2 secondary outcomes
demographic information1
Time frame: first day of birth
demographic information2
Time frame: first day of birth
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 1 Feb 2022.
- 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.
hatice adıgüzel, PhD principal investigator
Kahramanmaras Sutcu Imam 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 Cerebral Palsy and Infant, Premature, Diseases, run by Kahramanmaras Sutcu Imam 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 1 inclusion and 3 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 1 Feb 2022. 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?
Neonatal Magnetic Resonance Imaging (MRI) (time frame: at term age of infants (40 weeks), one assesment). The study lists 7 primary outcomes in all. 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 1 Feb 2022.