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Clinical 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 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).


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04259177
Study type Observational [Patient Registry]
Source Sanko University
Contact
Status Completed
Phase
Start date March 15, 2020
Completion date January 30, 2021

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