ClinicalTrials.Veeva

Menu

Associations Between Early Neonatal Neuroimaging, Hammersmith Infant Neurological Examination and General Movements (highrisk)

K

Kahramanmaraş Sütçü İmam University (KSU)

Status

Completed

Conditions

Infant, Premature, Diseases
Development Delay
Infant Asphyxia
Infant, Newborn, Disease
Infant, Very Low Birth Weight
Infant, Small for Gestational Age
Cerebral Palsy
Infant Development
Neurologic Disorder

Treatments

Diagnostic Test: Measurements

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

High risk infant is defined as infant with a negative history of environmental and biological factors, which can lead to neuromotor development problems. It is a heterogeneous group of premature infants born under thirty-seven weeks of age, with infants with low birth weight, term or developmental retardation for various reasons. Therefore, preterm infants with low birth weight can survive with a neurological sequelae such as cerebral palsy (CP), epilepsy, hearing and vision loss, mental retardation, speech and speech problems, and learning difficulties. The clinical diagnosis of CP, which can be observed in high-risk infants, is based on the combination of some neuroimaging and neurological examinations and assesments like neonatal imaging, general movements (GMs) and Hammersmith Infant Neurological Examination (HINE).

Full description

High-risk infants may encounter many problems in terms of motor, cognitive, sensory, social, and academic development. Premature and LBW infants are at higher risk in terms of motor and cognitive development problems. Approximately 50% of these infants encounter neurodevelopmental problems. These problems are related to gestational age (GA), birth weight, brain damage occurring during the prenatal/perinatal period, and medical risk factors. Prematurity and low birth weight (LBW) are also among the most important causes of CP. Three methods with the best predictable validity that can determine CP before the adjusted age of 5-month is Magnetic Resonance Imaging (MRI), Prechtl's Assessment of General Movements (GMs), Hammersmith Infant Neurological Evaluation (HINE). In recent years, the diagnosis of high-risk of CP can be detected at 3 months with predictive validity and reliability by evaluating the quality of GMs. GMs are now considered the gold standard for early detection of CP because of its high sensitivity and specificity than MRI, cranial US and neurological evaluations. It was also found that cognitive or language skills may be inadequate in school age in patients with inadequate movement character and in the same postural patterns according to age, although GMs are normal. So new clinical care guidelines and new intervention research for infants with CP under the age of 2, needs to be shown. So this study aims to examine the associations between early neonatal neuroimaging, HINE and GMs assessment in a Cohort of High Risk of Infants with one year of follow up.

Enrollment

63 patients

Sex

All

Ages

25 to 42 weeks old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Have periventricular hemorrhage, ICH stages 2, 3, 4, cystic PVL, stage 3 HIE, kernicterus, perinatal asphyxia, chronic lung disease, RDS, BPD, long-term oxygen (7 days), >24 hours mechanical ventilator (MV) support, 5th minute Apgar Score <3, neonatal sepsis, necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), gestation age <32 weeks, and prematurity due to preterm/multiple births<1500 gr.

Exclusion criteria

  • Infants with congenital malformation (Spina Bifida, Congenital Muscular Torticollis, Arthrogriposis Multiplex Congenita etc.)
  • Infants diagnosed with metabolic and genetic diseases (Down Syndrome,Spinal Muscular Atrophy, Duchenne Muscular Dystrophy etc.)
  • Infants still intubated and mechanical ventilator dependent at postterm 3 months.

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems