Clinical trial NCT04259177: Turkish Validity And Reliability Of The Hammersmith Infant Neurological Evaluation (Hine)
Official title: Turkish Validity And Reliability Of The Hammersmith Infant Neurological Evaluation (Hine)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Reliability
Infant Development
Infant, Premature, Diseases
Infant Asphyxia
Validity
Keywords: Reliability
Validity
Hammersmith Infant Neurological Evaluation (HINE)
Turkish version
Infant
Lead sponsor: Sanko University
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 35
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: magnetic resonance imaging (MRI)
timeFrame: first day of assessment
measure: Prechtl's general movements (GMs) analysis
timeFrame: up to 5 months
Secondary outcomes:
measure: prenatal,natal and postnatal risk factors
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Sanko University
state: Şehitkamil
Study officials:
affiliation: sanko Üniversitesi
name: hatice adıgüzel, PhD cd.
role: PRINCIPAL_INVESTIGATOR
References: