Cerebral PalsyHineNCT04259177
Turkish Validity And Reliability Of The Hammersmith Infant Neurological Evaluation (Hine)
An observational study of Cerebral Palsy and Reliability, run by Sanko University at 1 site in Turkey (Türkiye).
Trial summary
The high risk of infants are defined as having a negative environmental and biological factor history, where these factors can lead to neuromotor development problems. It is a heterogeneous group of premature babies born under the age of thirty-seven weeks, with a low birth weight term or infants with developmental… Read more about this study
- Who is it for?
- Ages 3 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Reliability, Infant Development
- What is being tested?
- Scale
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2020to 30 Jan 2021
- How long will I take part?
- 1 Month
- 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 3 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: * Infants with high risk of cerebral palsy (CP) with the age of 3-12 months. * Infants with healthy peers of high of cerebral palsy infants.
Who may be able to join
- Infants with periventricular hemorage, intracranial hemorage,grade 2, 3, 4, cystic periventricular leukomalacia, stage 3 hypoxic ischemic encephalopathy, neonatal bilirubin encephalopathy (kernicterius), perinatal stroke, perinatal asphyxia, hydrocephalus
- Chronic lung disease, respiratory lung disease (RDS), broncho pulmonary dysplasia and babies with long-term o₂ support
- Gram negative bacterial sepsis, necrotizing enterocolitis (NEC), infantile apnea, preterm babies with cerebral malformation
- Low Apgar score (3 and below), Preterm babies with intrauterine growth retardation, multiple births (twins, triplets), Premature Retinopathy (ROP)
- Infants with prolonged severe hypoglycaemia and hypocalcemia
- Surgical conditions such as diaphragmatic hernia or tracheoesophageal fistula
Show all 9Show fewer
- Infants who are small for gestational age (small for gestational age, sga, less than 3rd percentile) or large for gestational age (large for gestational age, LGA, greater than 97th percentile)
- Infants who received mechanical ventilation for more than 24 hours
- Infants younger than 32 gestational weeks and under 1500 kilograms
Who cannot join
- Infants with congenitalmal formation (spina bifida, congenital muscular torticollis, arthrogryposis multiplex congenita..vs)
- Infants diagnosed with metabolic and genetic diseases (down syndrome, spinal muscular atrophy, duchenne muscular dystrophy..vs)
- Postterm Infants still dependent on intubation and mechanical ventilator at 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
The high risk of infants are defined as having a negative environmental and biological factor history, where these factors can lead to neuromotor development problems. It is a heterogeneous group of premature babies born under the age of thirty-seven weeks, with a low birth weight term or infants with developmental retardation due to various reasons. Risk factors in preterm infants include perinatal asphyxia, hypoxic ischemic encephalopathy (HIE), periventricular leukomalacia (PVL), intraventricular hemorrhage (IVH), respiratory distress syndrome (RDS), broncho pulmonary dysplasia (BPD), hyperbilirubinemia, infection. alcohol syndrome, muscle tone disorders, low birth weight, hydrocephalus and microcephaly. These babies, especially preterm infants with low birth weight, may encounter a neurological sequence such as Cerebral Palsy (CP), epilepsy, hearing and vision loss, mental retardation, language-speech, behavioral problems and learning difficulties. CP is the most common disease of childhood, with the possibility of occurrence in 2-3 / 1000 live births.Today, the effectiveness of various methods has been proven to make early diagnosis of CP. One of these methods is the Hammersmith Infant Neurological Evaluation (HINE).
Read the detailed description
The diagnosis of CP, which can be observed with high risk infants, is based on the observation of many neurological and clinical signs. The diagnosis usually takes place between 12-24 months. In the past years, before 12-24 months, it was seen as a hidden or silent period that could not be fully defined in terms of CP. However, today this definition has been found invalid because the diagnosis of 'high risk of CP' or CP can be predicted precisely before the corrected 6 months.There are 3 methods with the best predictable validity of determining CP before the corrected 5-month period: Neonatal Magnetic Resonance Imaging (MRI) (86% -89% sensitivity), Prechtl's Qualitative General Movement Assessment (GMs) (98% sensitivity), Hammersmith Infant Neurological Evaluation (HINE) (90% sensitivity). Various difficulties are encountered in long-term follow-up of infants who are discharged from neonatal intensive care units (NICU) in developing countries. Many of these infants are referred to pediatricians or pediatric neurologists as needed. Others are not routinely monitored. However, in order to encourage more consistent and disciplined early assessments for high-risk infants, the guides applied should be adapted to neonatal follow-up clinics. For this reason, various health professionals working in the field of Pediatrics should be supported in providing objective tests and training materials in order to provide coordination and create a common language in the follow-up process. It is known that the HINE test does not require certification training and whose reliability is valid, does not have a Turkish version. Using proven methods to determine these needs and to direct the necessary professionals is a more important guide for clinicians. In order to meet the needs in this field, the Turkish version of the HINE scale in 6-12 months of infants was adapted and this validity and reliability study was planned.
- Conditions
- Cerebral Palsy, Reliability, Infant Development, Infant, Premature, Diseases, Infant Asphyxia, Validity
- Being tested
- Scale
- Keywords
- Reliability, Validity, Hammersmith Infant Neurological Evaluation (HINE), Turkish version, Infant
- Medical subject headings
- Cerebral Palsy, Infant, Premature, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScaleOther
Also called evaluation
This test is divided into 3 sections: neurological examination, developmental motor boundary stones and behavioral status, and consists of a total of 37 items. The first part consists of 26 items such as cranial nerve functions, posture, quality, amount of movements, muscle tone, reflex and reactions. The second part evaluates motor development boundary stones consisting of 8 items. The third part refers to the behavioral condition consisting of 3 items. These items can be easily scored. It can be rated as optimal or inadequate. Each item is scored separately (as 0, 1, 2, 3) and the final total score is calculated. The total score ranges from 0-78. The total score shows the global optimal scores.
What is being measured
The primary outcome is the main question the study is designed to answer.
magnetic resonance imaging (MRI)
magnetic resonnas imaging method is an imaging method that shows the parts of the brain that are damaged without oxygen. Imaging is obtained by sending rays to the brain with sound waves.
Measured: first day of assessment
Prechtl's general movements (GMs) analysis
Gms can identify neurological issues predictive of cerebral palsy and other developmental disabilities.GMs videos around 3 months of age (12-16 weeks corrected age) provide the most predictive information about the likelihood risk of cerebral palsy. Ther isn't maximum or cut off scores.Movements are noted as observed/or not. Also quality of fidgety movements are scored as low or high quality.
Measured: up to 5 months
Secondary outcomes (1)
prenatal,natal and postnatal risk factors
These parameter can be the risk of Cerebral Palsy for infants. Infants with periventricular bleeding, intracranial bleeding grade 2, 3, 4, cystic periventricular leukomalacia, stage 3 hypoxic ischemic encephalopathy, neonatal bilirubin encephalopathy (kernicterius), perinatal stroke, perinatal asphyxia, hydrocephalus.Chronic lung disease, respiratory lung disease (RSD), broncho pulmonary dysplasia and babies with long-term o₂ support Gram negative bacterial sepsis, necrotizing enterocolitis (NEC), preterm babies with cerebral malformation. Low Apgar score (3 and below), Preterm babies with intrauterine growth retardation, multiple births, Premature Retinopathy (ROP). Babies with prolonged severe hypoglycaemia and hypocalcemia. Infants who are small for gestational age or large for gestational age. Infants who received mechanical ventilation for more than 24 hours. Babies younger than 32 gestational weeks and under 1500 kilograms.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start15 Mar 2020
- Primary completion30 Jan 2021
- Study completion30 Jan 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
- Case-control
- Time perspective
- Other
- Enrolment
- 35 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Adıgüzel, Sanko University
- Investigators
- hatice adıgüzel, PhD cd., Principal investigator, sanko Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259177
- Sponsor's protocol ID
- SankoUnv
- Acronym
- Hine
- Status last verified
- Apr 2021
- First submitted
- 3 Feb 2020
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validity And Reliability Of The Hammersmith Infant Neurological Evaluation (Hine)
- ClinicalTrials.gov ID
- NCT04259177
- Acronym / sponsor ID
- Hine / SankoUnv
- Conditions
- Cerebral Palsy, Reliability, Infant Development, Infant, Premature, Diseases, Infant Asphyxia, Validity
- Keywords
- Reliability, Validity, Hammersmith Infant Neurological Evaluation (HINE), Turkish version, Infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 6 Feb 2020 (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.
The high risk of infants are defined as having a negative environmental and biological factor history, where these factors can lead to neuromotor development problems. It is a heterogeneous group of premature babies born under the age of thirty-seven weeks, with a low birth weight term or infants with developmental retardation due to various reasons. Risk factors in preterm infants include perinatal asphyxia, hypoxic ischemic encephalopathy (HIE), periventricular leukomalacia (PVL), intraventricular hemorrhage (IVH), respiratory distress syndrome (RDS), broncho pulmonary dysplasia (BPD), hyperbilirubinemia, infection. alcohol syndrome, muscle tone disorders, low birth weight, hydrocephalus and microcephaly. These babies, especially preterm infants with low birth weight, may encounter a neurological sequence such as Cerebral Palsy (CP), epilepsy, hearing and vision loss, mental retardation, language-speech, behavioral problems and learning difficulties. CP is the most common disease of childhood, with the possibility of occurrence in 2-3 / 1000 live births.Today, the effectiveness of various methods has been proven to make early diagnosis of CP. One of these methods is the Hammersmith Infant Neurological Evaluation (HINE).
Detailed description
The diagnosis of CP, which can be observed with high risk infants, is based on the observation of many neurological and clinical signs. The diagnosis usually takes place between 12-24 months. In the past years, before 12-24 months, it was seen as a hidden or silent period that could not be fully defined in terms of CP. However, today this definition has been found invalid because the diagnosis of 'high risk of CP' or CP can be predicted precisely before the corrected 6 months.There are 3 methods with the best predictable validity of determining CP before the corrected 5-month period: Neonatal Magnetic Resonance Imaging (MRI) (86% -89% sensitivity), Prechtl's Qualitative General Movement Assessment (GMs) (98% sensitivity), Hammersmith Infant Neurological Evaluation (HINE) (90% sensitivity). Various difficulties are encountered in long-term follow-up of infants who are discharged from neonatal intensive care units (NICU) in developing countries. Many of these infants are referred to pediatricians or pediatric neurologists as needed. Others are not routinely monitored. However, in order to encourage more consistent and disciplined early assessments for high-risk infants, the guides applied should be adapted to neonatal follow-up clinics. For this reason, various health professionals working in the field of Pediatrics should be supported in providing objective tests and training materials in order to provide coordination and create a common language in the follow-up process. It is known that the HINE test does not require certification training and whose reliability is valid, does not have a Turkish version. Using proven methods to determine these needs and to direct the necessary professionals is a more important guide for clinicians. In order to meet the needs in this field, the Turkish version of the HINE scale in 6-12 months of infants was adapted and this validity and reliability study was planned.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 3 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- * Infants with high risk of cerebral palsy (CP) with the age of 3-12 months. * Infants with healthy peers of high of cerebral palsy infants.
Key inclusion criteria (9 listed)
- Infants with periventricular hemorage, intracranial hemorage,grade 2, 3, 4, cystic periventricular leukomalacia, stage 3 hypoxic ischemic encephalopathy, neonatal bilirubin encephalopathy (kernicterius), perinatal stroke, perinatal asphyxia, hydrocephalus
- Chronic lung disease, respiratory lung disease (RDS), broncho pulmonary dysplasia and babies with long-term o₂ support
- Gram negative bacterial sepsis, necrotizing enterocolitis (NEC), infantile apnea, preterm babies with cerebral malformation
- Low Apgar score (3 and below), Preterm babies with intrauterine growth retardation, multiple births (twins, triplets), Premature Retinopathy (ROP)
- Infants with prolonged severe hypoglycaemia and hypocalcemia
Key exclusion criteria (3 listed)
- Infants with congenitalmal formation (spina bifida, congenital muscular torticollis, arthrogryposis multiplex congenita..vs)
- Infants diagnosed with metabolic and genetic diseases (down syndrome, spinal muscular atrophy, duchenne muscular dystrophy..vs)
- Postterm Infants still dependent on intubation and mechanical ventilator at 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 |
|---|---|---|
| ScaleAlso: evaluationThis test is divided into 3 sections: neurological examination, developmental motor boundary stones and behavioral status, and consists of a total of 37 items. The first part consists of 26 items such as cranial nerve functions, posture, quality, amount of movements, muscle tone, reflex and reactions. The second part evaluates motor development boundary stones consisting of 8 items. The third part refers to the behavioral condition consisting of 3 items. These items can be easily scored. It can be rated as optimal or inadequate. Each item is scored separately (as 0, 1, 2, 3) and the final total score is calculated. The total score ranges from 0-78. The total score shows the global optimal scores. | Other | – |
Primary outcome
magnetic resonance imaging (MRI)
Time frame: first day of assessment
magnetic resonnas imaging method is an imaging method that shows the parts of the brain that are damaged without oxygen. Imaging is obtained by sending rays to the brain with sound waves.
Prechtl's general movements (GMs) analysis
Time frame: up to 5 months
Gms can identify neurological issues predictive of cerebral palsy and other developmental disabilities.GMs videos around 3 months of age (12-16 weeks corrected age) provide the most predictive information about the likelihood risk of cerebral palsy. Ther isn't maximum or cut off scores.Movements are noted as observed/or not. Also quality of fidgety movements are scored as low or high quality.
1 secondary outcome
prenatal,natal and postnatal risk factors
Time frame: up to 1 year
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 19 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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 cd. principal investigator
sanko Üniversitesi
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 Reliability, run by Sanko 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 9 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 19 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?
magnetic resonance imaging (MRI) (time frame: first day of assessment). 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?
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 19 Apr 2021.