RecruitingNot Applicable

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

Turkey (Türkiye)120 participantsStarted 2025-08-22

Plain-language summary

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.

Who can participate

Age range

3 Months – 12 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Hammersmith Infant Neurological Examination (HINE)

Timeframe: HINE will be administered to all infants at 3, 6, and 12 months.

BRIEF-HINE

Timeframe: BRIEF-HINE will be administered to all infants at 3, 6, and 12 months.

Trial details

NCT IDNCT07182474

SponsorKahramanmaras Sutcu Imam University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-09-15

Contact for this trial

Hatice adıgüzel tat, Associate Proffessor

+90 344 300 26 47 fzthatis@gmail.com

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