Turkish Version of the Hammersmith Neonatal Neurological Examination (HNNE)

NCT07182513 | Recruiting

• 2 other identifiers: HNNEUNIVERSİTY
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

High-risk infants 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 high-risk infants 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

Outcome Measures

Primary Outcomes (1)

• 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.

  one assessment at the term equivalent age (37-40 weeks)

Secondary Outcomes (3)

• Demographic form

  one assessment at term equivalent age (37-40 weeks)

• Pretchl's General Movements (GMs) Assessment

  2 assessments (first at writing term age (from birth to 47 weeks), second at fidgety term age (49-60 weeks)

• Hammersmith Infant Neurological Examination

  3, 6, 9 and 12 months of age (4 times)

Study Arms (1)

1

High-risk infants 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 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 g.

Eligibility Criteria

• Age: 37 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Neonatal infants at term equivalent age (TEA) of 37-42 weeks with high risk of cerebral palsy

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead
• Gazi University: collaborator

Study Sites (1)

Kahramanmaraş Sütçü imam University

Kahramanmaraş, Onikişubat, 46100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Bülent Elbasan, Proffessor

  Gazi University

  STUDY CHAIR

• Hatice adıgüzel tat, Associate Proffessor

  Kahramanmaras Sutcu Imam University

  PRINCIPAL INVESTIGATOR

• Sadık Yurttutan, Proffessor

  Kahramanmaras Sutcu Imam University

  STUDY CHAIR

• Hidayet Cuhaoğlu, Lecturer

  Kastamonu University

  STUDY CHAIR

• Halil İbrahim Celik, Associate Proffessor

  Bilge Çocuk Special Education and Rehabilitation Center

  STUDY CHAIR

Central Study Contacts

hatice adıgüzel tat, Associate Proffessor

CONTACT

+905056491048; fzthatis@gmail.com

hatice Adiguzel tat Associate Proffessor, Pt, PhD

CONTACT

+905056491048; fzthatis@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 19, 2025
• Study Start: August 22, 2025
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)