Turkish Validity And Reliability Of The Hammersmith Infant Neurological Evaluation (Hine)

NCT04259177 | Completed

• 1 other identifier: SankoUnv
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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).

Conditions

Cerebral Palsy; Reliability; Infant Development; Infant, Premature, Diseases; Infant Asphyxia; Validity

Keywords

Reliability; Validity; Hammersmith Infant Neurological Evaluation (HINE); Turkish version; Infant

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• prenatal,natal and postnatal risk factors

  up to 1 year

Interventions

Scale OTHER

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.

Also known as: evaluation

Eligibility Criteria

• Age: 3 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanko University: lead

Study Sites (1)

Sanko University

Gaziantep, Şehitkamil, 27090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy; Infant, Premature, Diseases

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• hatice adıgüzel, PhD cd.

  sanko Üniversitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc PhD. cd. Lecturer

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 6, 2020
• Study Start: March 15, 2020
• Primary Completion: January 30, 2021
• Study Completion: January 30, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

TU (1)