Cerebral Palsy (CP)HNNENCT07182513
Turkish Version of the Hammersmith Neonatal Neurological Examination (HNNE)
An observational study of Cerebral Palsy (CP) and Infant ALL, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Infants at risk are defined as an infant with a history of adverse environmental and biological factors that may lead to neuromotor developmental problems. This group includes premature babies born at less than 37 weeks, term babies with low birth weight (LBW), or babies with developmental delays due to various… Read more about this study
- Who is it for?
- Ages 37 to 42 weeks
- Conditions the study is for
- Cerebral Palsy (CP), Infant ALL, Neurological Development
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Aug 2025to 15 May 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 37 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Neonatal infants at term equivalent age (TEA) of 37-42 weeks with high risk of cerebral palsy
Who may be able to join
- Infants with periventricular hemorrhage, intracranial hemorrhage grades 2, 3, or 4, cystic periventricular leukomalacia (PVL), stage 3 hypoxic ischemic encephalopathy, neonatal bilirubin encephalopathy (kernicterus), perinatal stroke, perinatal asphyxia, and hydrocephalus.
- Infants with chronic lung disease, respiratory lung disease (RDS), bronchopulmonary dysplasia (BPD), and long-term oxygen supplementation.
- Preterm infants with sepsis due to gram-negative bacteria, necrotizing enterocolitis (NEC), and infantile apnea.
- Preterm infants with a low 5-minute Apgar score (3 or below), diagnosed with intrauterine growth restriction, multiple births (twins, triplets), and preterm infants with Retinopathy of Prematurity (ROP).
- Infants with prolonged severe hypoglycemia and hypocalcemia.
- Babies who are small for gestational age (SGA), less than the 3rd percentile, or large for gestational age (LGA), greater than the 97th percentile.
- Babies receiving mechanical ventilation for more than 24 hours.
- Babies born at less than 32 weeks' gestation and weighing less than 1500 grams.
Who cannot join
- Babies with congenital malformations (spina bifida, congenital muscular torticollis, arthrogryposis multiplex congenita, etc.)
- Babies diagnosed with metabolic and genetic diseases (Down syndrome, spinal muscular atrophy, Duchenne muscular dystrophy, etc.)
- Babies still intubated and mechanically ventilated at 3 months postterm
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Sütçü imam University
Kahramanmaraş, Onikişubat, 46100
About this study
Official title: Turkish Version of the Hammersmith Neonatal Neurological Examination (HNNE) With Infants at Risk: A Study of Validity and Reliability
Infants at risk are defined as an infant with a history of adverse environmental and biological factors that may lead to neuromotor developmental problems. This group includes premature babies born at less than 37 weeks, term babies with low birth weight (LBW), or babies with developmental delays due to various reasons. These babies are also monitored for cerebral palsy (CP). CP is the most common physical disability in childhood, with an incidence of 2.1 per 1000 births. CP encompasses a group of permanent impairments in movement and posture development resulting from injury to the developing brain. Thanks to preventive measures and advances in obstetric and neonatal care, the incidence and severity of CP are currently decreasing in some countries, and it is emphasized that recovery can be more rapid with the use of early diagnosis guidelines or protocols in follow-up units. Early detection and monitoring of infants in the community for CP is essential only with appropriate, valid, and reliable tools to minimize potential sequelae through the timely implementation of CP-specific interventions. International guidelines require monitoring of infants at high risk of CP. This follow-up should be conducted by an interdisciplinary team, including a neonatologist, pediatrician, pediatric neurologist, pediatric physiotherapist, speech-language-swallowing therapist, and special education specialist. Pediatric physiotherapists are an important part of this team for developmental follow-up and rehabilitation. The Hammersmith Neonatal Neurological Examination (HNNE) is a method developed by Dubowitz and used in both clinical and research neurological examinations of preterm and term infants, is the neonatal form of the Hammersmith Infant Neurological Examination (HINE). Its use in the Neonatal Intensive Care Unit (NICU) is crucial for beginning risk assessment as early as possible. Research has determined the optimality score for this test for term infants evaluated in the first days after birth. Subsequently, the current version of the HNNE was standardized by evaluating low-risk term and high-risk preterm infants (25-34 weeks) at term ages, 6-48 hours after birth.The aim of this study was to develop a Turkish version of the HNNE for infants at risk in Turkey and determine its validity and reliability. The translated HNNE version, which was found to be valid and reliable in this population, will be suitable for use by all healthcare professionals in Turkey. This study also aimed to determine the predictive value of HNNE at corrected 3-4/6 and 12 months when used in the follow-up of at-risk infants in NICUs in Turkey.The study consists of two phases. The first phase consisted of translating the short version of the survey into Turkish and conducting its cultural adaptation. The second phase involved reliability analysis. The principles of Guillemin et al. and Beaton et al. will be used in the translation and cultural adaptation processes.
- Conditions
- Cerebral Palsy (CP), Infant ALL, Neurological Development, Neonatal
- Medical subject headings
- Cerebral Palsy
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 being followed in the NICU of the University Hospital's Faculty of Medicine will be included. A total of 120±10 high-risk infants will be included in the study, representing 10 times the number of items in the HNNE short version. Infants with 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 g. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hammersmith Neonatal Neurological Examination (HNNE)
The HNNE consists of a standard 34-item proforma. Each item is numbered 3 to 5. These items are scored from 1 to 3. When an item falls between two columns, it is assigned the appropriate half-score within the columns (e.g., items scored between 2 and 3 receive 2.5 points; items scored between 1 and 2 receive 1.5 points). High scores indicate good neurological status.The items in this proforma are; It is divided into six categories: tone (10), tone patterns (5), reflexes (6), movements (3), abnormal symptoms (3), and behavior (7). The scores from these subsections are summed to create an optimality score for preterm and term infants. The short version of the scale consists of 12 items (12,13). The short HNNM scale will be scored by a physical therapist on all high-risk infants in the NICU, using a fixed tripod and video recording in an environment away from stimuli.HNNE wıll be scored 4 times for test-retest and inter-observer reliability.
Measured: one assessment at the term equivalent age (37-40 weeks)
Secondary outcomes (3)
Demographic form
It will consist of a form that includes prenatal and postnatal risk factors of all infants, demographic information of infants and parents, and neurological evaluation, cranial US and MRI results of infants, if any.
Measured: one assessment at term equivalent age (37-40 weeks)
Pretchl's General Movements (GMs) Assessment
Heinz Prechtl demonstrated the validity and reliability of this method by determining that infants without fidgety movements (FMs) at 3-5 months of age are at increased risk of developing CP. GMs assessment is performed at three stages: preterm, writhing, and fidgety.According to the Prechtl method, abnormal movements during the preterm and writhing stages are classified as poor repertoire (PR), cramped synchronized (CS), and chaotic (Ch) GMs.During this period, fidgety movements are scored as F+, absent (F-) or abnormal (AF).
Measured: 2 assessments (first at writing term age (from birth to 47 weeks), second at fidgety term age (49-60 weeks)
Hammersmith Infant Neurological Examination
It is administered to analyze the risk of neurological anomalies in preterm and term infants. This test is known to be a prognostic battery for identifying neural disorders in infants between 2 and 24 months postnatally. The HINM consists of a total of 37 items, divided into three sections: neurological examination, developmental motor milestones, and behavioral status. Administration time is 5-10 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 HINM test's optimality score and cut-off scores for CP at 3, 6, 9, 12, and 24 months provides prognostic information regarding the level of motor development.The HINE will be applied to all babies at 3, 6, 9 and 12 months and the cut-off scores for CP will be interpreted.
Measured: 3, 6, 9 and 12 months of age (4 times)
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 May 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Principal investigator, Hatice Adiguzel, Kahramanmaras Sutcu Imam University
- Investigators
- Bülent Elbasan, Proffessor, Study chair, Gazi UniversityHatice adıgüzel tat, Associate Proffessor, Principal investigator, Kahramanmaras Sutcu Imam UniversitySadık Yurttutan, Proffessor, Study chair, Kahramanmaras Sutcu Imam UniversityHidayet Cuhaoğlu, Lecturer, Study chair, Kastamonu UniversityHalil İbrahim Celik, Associate Proffessor, Study chair, Bilge Çocuk Special Education and Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182513
- Sponsor's protocol ID
- HNNE
- Other IDs
- UNIVERSİTY
- Acronym
- HNNE
- Status last verified
- Sep 2025
- First submitted
- 4 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 Hammersmith Neonatal Neurological Examination (HNNE) With Infants at Risk: A Study of Validity and Reliability
- ClinicalTrials.gov ID
- NCT07182513
- Acronym / sponsor ID
- HNNE / HNNE
- Conditions
- Cerebral Palsy (CP), Infant ALL, Neurological Development, Neonatal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- 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.
Infants at risk are defined as an infant with a history of adverse environmental and biological factors that may lead to neuromotor developmental problems. This group includes premature babies born at less than 37 weeks, term babies with low birth weight (LBW), or babies with developmental delays due to various reasons. These babies are also monitored for cerebral palsy (CP). CP is the most common physical disability in childhood, with an incidence of 2.1 per 1000 births. CP encompasses a group of permanent impairments in movement and posture development resulting from injury to the developing brain. Thanks to preventive measures and advances in obstetric and neonatal care, the incidence and severity of CP are currently decreasing in some countries, and it is emphasized that recovery can be more rapid with the use of early diagnosis guidelines or protocols in follow-up units. Early detection and monitoring of infants in the community for CP is essential only with appropriate, valid, and reliable tools to minimize potential sequelae through the timely implementation of CP-specific interventions. International guidelines require monitoring of infants at high risk of CP. This follow-up should be conducted by an interdisciplinary team, including a neonatologist, pediatrician, pediatric neurologist, pediatric physiotherapist, speech-language-swallowing therapist, and special education specialist. Pediatric physiotherapists are an important part of this team for developmental follow-up and rehabilitation. The Hammersmith Neonatal Neurological Examination (HNNE) is a method developed by Dubowitz and used in both clinical and research neurological examinations of preterm and term infants, is the neonatal form of the Hammersmith Infant Neurological Examination (HINE). Its use in the Neonatal Intensive Care Unit (NICU) is crucial for beginning risk assessment as early as possible. Research has determined the optimality score for this test for term infants evaluated in the first days after birth. Subsequently, the current version of the HNNE was standardized by evaluating low-risk term and high-risk preterm infants (25-34 weeks) at term ages, 6-48 hours after birth.The aim of this study was to develop a Turkish version of the HNNE for infants at risk in Turkey and determine its validity and reliability. The translated HNNE version, which was found to be valid and reliable in this population, will be suitable for use by all healthcare professionals in Turkey. This study also aimed to determine the predictive value of HNNE at corrected 3-4/6 and 12 months when used in the follow-up of at-risk infants in NICUs in Turkey.The study consists of two phases. The first phase consisted of translating the short version of the survey into Turkish and conducting its cultural adaptation. The second phase involved reliability analysis. The principles of Guillemin et al. and Beaton et al. will be used in the translation and cultural adaptation processes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Infants at risk being followed in the NICU of the University Hospital's Faculty of Medicine will be included. A total of 120±10 high-risk infants will be included in the study, representing 10 times the number of items in the HNNE short version. Infants with 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 g. |
Who may qualify
- Ages
- 37 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonatal infants at term equivalent age (TEA) of 37-42 weeks with high risk of cerebral palsy
Key inclusion criteria (8 listed)
- Infants with periventricular hemorrhage, intracranial hemorrhage grades 2, 3, or 4, cystic periventricular leukomalacia (PVL), stage 3 hypoxic ischemic encephalopathy, neonatal bilirubin encephalopathy (kernicterus), perinatal stroke, perinatal asphyxia, and hydrocephalus.
- Infants with chronic lung disease, respiratory lung disease (RDS), bronchopulmonary dysplasia (BPD), and long-term oxygen supplementation.
- Preterm infants with sepsis due to gram-negative bacteria, necrotizing enterocolitis (NEC), and infantile apnea.
- Preterm infants with a low 5-minute Apgar score (3 or below), diagnosed with intrauterine growth restriction, multiple births (twins, triplets), and preterm infants with Retinopathy of Prematurity (ROP).
- Infants with prolonged severe hypoglycemia and hypocalcemia.
Key exclusion criteria (3 listed)
- Babies with congenital malformations (spina bifida, congenital muscular torticollis, arthrogryposis multiplex congenita, etc.)
- Babies diagnosed with metabolic and genetic diseases (Down syndrome, spinal muscular atrophy, Duchenne muscular dystrophy, etc.)
- Babies still intubated and mechanically ventilated at 3 months postterm
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
Hammersmith Neonatal Neurological Examination (HNNE)
Time frame: one assessment at the term equivalent age (37-40 weeks)
The HNNE consists of a standard 34-item proforma. Each item is numbered 3 to 5. These items are scored from 1 to 3. When an item falls between two columns, it is assigned the appropriate half-score within the columns (e.g., items scored between 2 and 3 receive 2.5 points; items scored between 1 and 2 receive 1.5 points). High scores indicate good neurological status.The items in this proforma are; It is divided into six categories: tone (10), tone patterns (5), reflexes (6), movements (3), abnormal symptoms (3), and behavior (7). The scores from these subsections are summed to create an optimality score for preterm and term infants. The short version of the scale consists of 12 items (12,13). The short HNNM scale will be scored by a physical therapist on all high-risk infants in the NICU, using a fixed tripod and video recording in an environment away from stimuli.HNNE wıll be scored 4 times for test-retest and inter-observer reliability.
3 secondary outcomes
Demographic form
Time frame: one assessment at term equivalent age (37-40 weeks)
Pretchl's General Movements (GMs) Assessment
Time frame: 2 assessments (first at writing term age (from birth to 47 weeks), second at fidgety term age (49-60 weeks)
Hammersmith Infant Neurological Examination
Time frame: 3, 6, 9 and 12 months of age (4 times)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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. This study is not recruiting at the moment.
Bülent Elbasan, Proffessor study chair
Gazi University
Hatice adıgüzel tat, Associate Proffessor principal investigator
Kahramanmaras Sutcu Imam University
Sadık Yurttutan, Proffessor study chair
Kahramanmaras Sutcu Imam University
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 Cerebral Palsy (CP) and Infant ALL, 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 8 inclusion and 3 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hammersmith Neonatal Neurological Examination (HNNE) (time frame: one assessment at the term equivalent age (37-40 weeks)). 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.