Hammersmith newborn neurological exam in Turkish
Turkish Version of the Hammersmith Neonatal Neurological Examination (HNNE) With High-Risk of Infants: A Study of Validity and Reliability
This project tests whether the Turkish version of the Hammersmith Neonatal Neurological Examination can help detect neurological problems in high-risk newborns such as preterm or low-birthweight infants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 37 Weeks to 42 Weeks |
| Sex | All |
| Sponsor | Kahramanmaras Sutcu Imam University Academic / other |
| Locations | 1 site (Kahramanmaraş, Onikişubat) |
| Trial ID | NCT07182513 on ClinicalTrials.gov |
What this trial studies
This observational project applies a Turkish-language version of the Hammersmith Neonatal Neurological Examination (HNNE) to infants considered at high risk for neuromotor problems. Clinicians at the site will perform the HNNE during routine neonatal follow-up and record scores alongside the infants' clinical histories and diagnostic information. The effort focuses on reliability and clinical usefulness of the translated tool by comparing exam findings with known diagnoses and follow-up outcomes. Results are intended to determine whether the Turkish HNNE provides consistent, clinically meaningful information for early detection and monitoring.
Who should consider this trial
Good fit: Ideal candidates are newborns and infants considered high-risk for neuromotor problems, including preterm infants, low- or high-birthweight babies, infants with intracranial hemorrhage, hypoxic‑ischemic events, severe metabolic disturbances, infections, or other listed neonatal complications.
Not a fit: Healthy term infants without neonatal complications or children beyond the newborn/neonatal follow-up period are unlikely to gain direct benefit from this project.
Why it matters
Potential benefit: If successful, the Turkish HNNE could enable earlier and more consistent detection of neuromotor problems in high-risk newborns, supporting timely follow-up and intervention.
How similar studies have performed: The HNNE is an established neonatal neurological exam and validations in other languages and settings have been successful, while the Turkish version itself is newly implemented in this program.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. Infants with chronic lung disease, respiratory lung disease (RDS), bronchopulmonary dysplasia (BPD), and long-term oxygen supplementation. 3. Preterm infants with sepsis due to gram-negative bacteria, necrotizing enterocolitis (NEC), and infantile apnea. 4. 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). 5. Infants with prolonged severe hypoglycemia and hypocalcemia. 6. Babies who are small for gestational age (SGA), less than the 3rd percentile, or large for gestational age (LGA), greater than the 97th percentile. 7. Babies receiving mechanical ventilation for more than 24 hours. 8. Babies born at less than 32 weeks' gestation and weighing less than 1500 grams. Exclusion Criteria: 1. Babies with congenital malformations (spina bifida, congenital muscular torticollis, arthrogryposis multiplex congenita, etc.) 2. Babies diagnosed with metabolic and genetic diseases (Down syndrome, spinal muscular atrophy, Duchenne muscular dystrophy, etc.) 3. Babies still intubated and mechanically ventilated at 3 months postterm
Where this trial is running
Kahramanmaraş, Onikişubat
- Kahramanmaraş Sütçü imam University — Kahramanmaraş, Onikişubat, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Hatice adıgüzel tat, Associate Proffessor — Kahramanmaras Sutcu Imam University
- Study coordinator: hatice adıgüzel tat, Associate Proffessor
- Email: fzthatis@gmail.com
- Phone: +905056491048
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.