Recruiting NCT07182474

Turkish Version of the BRIEF-Hammersmith Infant Neurological Examination (HINE)

— Observational Pediatrics Neurological Abnormality Neurodevelopment Outcome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Pediatrics, Neurological Abnormality, Neurodevelopment Outcome. Basic parameters: 3 months — 12 months · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Turkey (Türkiye)
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Turkish Version of the BRIEF-Hammersmith Infant Neurological Examination (HINE) With Infants at Risk: A Study of Validity and Reliability

Overview

The American Academy of Pediatrics defines infants at risk as those with preterm birth, special health care needs, family risk factors, and those at risk of early death. Factors such as premature birth, perinatal asphyxia, hypoxic-ischemic encephalopathy (HIE), periventricular leukomalacia (PVL), intraventricular hemorrhage (IVH), chronic lung disease, seizures, meningitis, hyperbilirubinemia, twin/triplet pregnancy, and intrauterine growth restriction are risk factors that can result in morbidity and mortality in infants. Regular neurological examinations and neuromotor tests are necessary for at-risk infants to identify developmental problems early and to initiate early intervention programs.In developing countries, regular follow-up and early rehabilitation of at-risk infants are not successfully implemented. 5,6 The lengthy test batteries and busy clinics are among the most significant reasons. Therefore, the development and dissemination of shorter, valid, and reliable tests is of great importance. The Hammersmith Neonatal Neurological Examination (HINE), one of the gold standard methods, consists of 26 items and takes 15-20 minutes to administer.Due to the number of items and the duration, it is not frequently used routinely. In response to this clinical need, the HINE short scale was developed in 2024.The aim of the study is to have a Turkish version of the Abstract-HINE test in Turkey and to study its validity and reliability in infants at risk.

Primary outcome measures

The Hammersmith Infant Neurological Examination (HINE) [Time frame: HINE will be administered to all infants at 3, 6, and 12 months.]
BRIEF-HINE [Time frame: BRIEF-HINE will be administered to all infants at 3, 6, and 12 months.]

Secondary outcome measures (1)

sosyodemographic form: [Time frame: Day 1 (at the first time of assessment)]

Eligibility criteria

Inclusion criteria

Infants with high risk of CP: Periventricular hemorrhage, intracranial hemorrhage grade 2, 3, 4, cystic PVL, stage 3 hypoxic ischemic encephalopathy, neonatal bilirubin encephalopathy (kernicterus), perinatal stroke, perinatal asphyxia, respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD) and infants receiving long-term O₂ support, sepsis due to gram-negative bacteria, necrotizing enterocolitis (NEC), infantile apnea, those with a low 5-minute Apgar score (3 and below), those diagnosed with intrauterine growth retardation, multiple births (twins, triplets), preterm infants with retinopathy of prematurity (ROP), infants with prolonged severe hypoglycemia and hypocalcemia, (small for gestational age (SGA), less than the 3rd percentile) or large for gestational age (large for gestational age (LGA), less than the 97th percentile). (large) babies, babies receiving mechanical ventilation for more than 24 hours, babies born at less than 32 weeks of gestation and weighing less than 1500 grams.

Exclusion criteria

Infants with any known orthopedic, systemic disease or neurological diagnosis other than CP

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

Turkey (Türkiye) · 1 center

Kahramanmaraş Sütçü imam University — Kahramanmaraş

Identifiers

NCT: NCT07182474 · BRIEF-HINE

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗