PediatricsBRIEF-HINENCT07182474
Turkish Version of the BRIEF-Hammersmith Infant Neurological Examination (HINE)
An observational study of Pediatrics and Neurological Abnormality, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 12 months
- Conditions the study is for
- Pediatrics, Neurological Abnormality, Neurodevelopment Outcome
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Aug 2025to 30 Oct 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: 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, RDS, BPD and infants receiving long-term O₂ support, sepsis due to gram-negative bacteria, NEC, infantile apnea, those with a low 5th minute Apgar score (3 and below), those diagnosed with intrauterine growth retardation, multiple births (twins, triplets), preterm infants with ROP, infants with prolonged severe hypoglycemia and hypocalcemia, infants who are SGA or LGA, infants receiving mechanical ventilation for more than 24 hours, infants born less than 32 weeks of gestation and weighing less than 1500 grams)
Who may be able to join
- 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.
Who cannot join
- Infants with any known orthopedic, systemic disease or neurological diagnosis other than CP
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
hatice Adiguzel tat, Associate Proffessor contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kahramanmaraş Sütçü imam University
Kahramanmaraş, Onikişubat, 46100
Hatice adıgüzel tat, associate professor, +90 344 300 26 47, fzthatis@gmail.com
Hatice Adigüzel Tat, associate professor, +90344 300 26 47, fzthatis@gmail.com
About this study
Official title: Turkish Version of the BRIEF-Hammersmith Infant Neurological Examination (HINE) With Infants at Risk: A Study of Validity and Reliability
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.
- Medical subject headings
- Nervous System Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Infants at risk referred to the Pediatric Rehabilitation Unit for follow-up will be included. A total of 110±10 infants at risk will be included in the study, representing 10 times the number of items in the Abstract-HINE version. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Hammersmith Infant Neurological Examination (HINE)
The Hammersmith Infant Neurological Examination (HINE) was developed by Dubowitz and colleagues from a standard neurological examination of newborns. It analyzes the risk of neurological anomalies in preterm and term infants. This test is a prognostic battery for identifying neuromotor disorders in infants between 2 and 24 months postnatally. The HINE scale consists of 37 items divided into three sections: neurological examination, developmental motor milestones, and behavioral status. Administration time is 10-15 minutes. Optimization scores for infants aged 3 to 18 months are based on the frequency distribution of neurological findings in the population in that age group. An item is considered optimal when present in at least 90% of infants. Use of the HINE test's optimality score and cut-off scores for CP at 3, 6, 9, 12, and 24 months provide prognostic information regarding the level of motor development. the HINE will be administered to all infants at 3, 6, and 12 months.
Measured: HINE will be administered to all infants at 3, 6, and 12 months.
BRIEF-HINE
The short form is an 11-item test that takes approximately 5 minutes.This short form includes the 11 subitems of the original HINE, developed by Romeo et al. for use in at-risk infants between 3 and 12 months of age. The item assessment and scoring are the same as the original format, with a 0-3 scale. The total scale score ranges from 0 to 33, with a higher score indicating better neuromotor performance. The test has cut-off values for 3, 6, 9, and 12 months, allowing for categorization of typical/atypical development. The test takes an average of 5 minutes to administer and is well-suited for routine use. The HINE is a valid and reliable test with predictive value, and its Turkish translation has been completed. This study will interpret the cut-off scores for CP.
Measured: BRIEF-HINE will be administered to all infants at 3, 6, and 12 months.
Secondary outcomes (1)
sosyodemographic form:
It will consist of a form that includes prenatal and postnatal risk factors of all infants, demographic information of infants and their parents, and, if available, neurological evaluation, cranial ultrasound (cUS) and Magnetic Resonance Imaging (MRI) results of the infants.
Measured: Day 1 (at the first time of assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start22 Aug 2025
- Primary completion15 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Adiguzel, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182474
- Sponsor's protocol ID
- BRIEF-HINE
- Acronym
- BRIEF-HINE
- Status last verified
- Aug 2025
- First submitted
- 11 Sep 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Version of the BRIEF-Hammersmith Infant Neurological Examination (HINE) With Infants at Risk: A Study of Validity and Reliability
- ClinicalTrials.gov ID
- NCT07182474
- Acronym / sponsor ID
- BRIEF-HINE / BRIEF-HINE
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Infants at risk referred to the Pediatric Rehabilitation Unit for follow-up will be included. A total of 110±10 infants at risk will be included in the study, representing 10 times the number of items in the Abstract-HINE version. |
Who may qualify
- Ages
- 3 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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, RDS, BPD and infants receiving long-term O₂ support, sepsis due to gram-negative bacteria, NEC, infantile apnea, those with a low 5th minute Apgar score (3 and below), those diagnosed with intrauterine growth retardation, multiple births (twins, triplets), preterm infants with ROP, infants with prolonged severe hypoglycemia and hypocalcemia, infants who are SGA or LGA, infants receiving mechanical ventilation for more than 24 hours, infants born less than 32 weeks of gestation and weighing less than 1500 grams)
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Infants with any known orthopedic, systemic disease or neurological diagnosis other than CP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Hammersmith Infant Neurological Examination (HINE)
Time frame: HINE will be administered to all infants at 3, 6, and 12 months.
The Hammersmith Infant Neurological Examination (HINE) was developed by Dubowitz and colleagues from a standard neurological examination of newborns. It analyzes the risk of neurological anomalies in preterm and term infants. This test is a prognostic battery for identifying neuromotor disorders in infants between 2 and 24 months postnatally. The HINE scale consists of 37 items divided into three sections: neurological examination, developmental motor milestones, and behavioral status. Administration time is 10-15 minutes. Optimization scores for infants aged 3 to 18 months are based on the frequency distribution of neurological findings in the population in that age group. An item is considered optimal when present in at least 90% of infants. Use of the HINE test's optimality score and cut-off scores for CP at 3, 6, 9, 12, and 24 months provide prognostic information regarding the level of motor development. the 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.
The short form is an 11-item test that takes approximately 5 minutes.This short form includes the 11 subitems of the original HINE, developed by Romeo et al. for use in at-risk infants between 3 and 12 months of age. The item assessment and scoring are the same as the original format, with a 0-3 scale. The total scale score ranges from 0 to 33, with a higher score indicating better neuromotor performance. The test has cut-off values for 3, 6, 9, and 12 months, allowing for categorization of typical/atypical development. The test takes an average of 5 minutes to administer and is well-suited for routine use. The HINE is a valid and reliable test with predictive value, and its Turkish translation has been completed. This study will interpret the cut-off scores for CP.
1 secondary outcome
sosyodemographic form:
Time frame: Day 1 (at the first time of assessment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
hatice Adiguzel tat, Associate Proffessor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatrics and Neurological Abnormality, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hatice adıgüzel tat, Associate Proffessor (+90 344 300 26 47, fzthatis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Hammersmith Infant Neurological Examination (HINE) (time frame: HINE will be administered to all infants at 3, 6, and 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.