Cerebral Palsy Clinical Trial
— HineOfficial title:
Turkish Validity And Reliability Of The Hammersmith Infant Neurological Evaluation (Hine)
NCT number | NCT04259177 |
Other study ID # | SankoUnv |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 15, 2020 |
Est. completion date | January 30, 2021 |
Verified date | April 2021 |
Source | Sanko University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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).
Status | Completed |
Enrollment | 35 |
Est. completion date | January 30, 2021 |
Est. primary completion date | January 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Months to 12 Months |
Eligibility | Inclusion Criteria: - 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 - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Sanko University | Gaziantep | Sehitkamil |
Lead Sponsor | Collaborator |
---|---|
Sanko University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | first day of assessment | |
Primary | 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. | up to 5 months | |
Secondary | 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. | up to 1 year |
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