Actively Recruiting

Age: 37Weeks - 42Weeks
All Genders
ID07182513

Turkish Version of the Hammersmith Neonatal Neurological Examination (HNNE) for High-Risk Infants: Validity and Reliability Study

Led by Kahramanmaras Sutcu Imam University · Updated on 2025-09-19

120

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

K

Kahramanmaras Sutcu Imam University

Lead Sponsor

G

Gazi University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the Turkish version of the Hammersmith Neonatal Neurological Examination (HNNE) to assess its validity and reliability for monitoring high-risk infants in Turkey. High-risk infants include those born prematurely, with low birth weight, or with developmental delays and conditions that may lead to cerebral palsy (CP). CP is a common childhood physical disability caused by brain injury during development, and early detection is crucial for timely intervention and better outcomes. The study involves translating and culturally adapting the HNNE tool into Turkish, followed by reliability testing. It includes 120 high-risk infants followed in the Neonatal Intensive Care Unit (NICU) with various conditions such as brain hemorrhages, hypoxic injuries, infections, respiratory diseases, and growth abnormalities. These infants are assessed using the HNNE at term equivalent age (37-40 weeks) along with other neurological assessments at multiple time points up to 12 months. During the study, participants undergo neurological examinations including the HNNE, Pretchl's General Movements assessment, and the Hammersmith Infant Neurological Examination at set intervals. Researchers collect demographic data and monitor neurological development to determine the predictive value of the HNNE. The involvement includes one primary assessment at term age and follow-ups at 3, 6, 9, and 12 months, focusing on early detection of CP and other developmental issues.

CONDITIONS

Brief Title

Turkish Version of the Hammersmith Neonatal Neurological Examination (HNNE)

Who Can Participate

Age: 37Weeks - 42Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 distress syndrome (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 of 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 (less than 3rd percentile) or large for gestational age (greater than 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
Not Eligible

You will not qualify if you...

  • Babies with congenital malformations such as spina bifida, congenital muscular torticollis, or arthrogryposis multiplex congenita
  • Babies diagnosed with metabolic or genetic diseases including Down syndrome, spinal muscular atrophy, or Duchenne muscular dystrophy
  • Babies still intubated and mechanically ventilated at 3 months postterm

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - From birth to 12 months of age

Participants undergo neurological assessments including the Hammersmith Neonatal Neurological Examination (HNNE) and Pretchl's General Movements (GMs) assessments at specified ages.

1 assessment at term equivalent age (37-40 weeks), 2 assessments between birth and 60 weeks, and 4 assessments at 3, 6, 9, and 12 months of age

Trial Site Locations

Total: 1 location

1

Kahramanmaraş Sütçü imam University

Kahramanmaraş, Onikişubat, Turkey (Türkiye), 46100

Actively Recruiting

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Research Team

H

hatice adıgüzel tat, Associate Proffessor

H

hatice Adiguzel tat Associate Proffessor, Pt, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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