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

NCT ID: NCT05217186

Last Updated: 2022-02-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 63 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2021-10-15

Brief Summary

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).

Detailed 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Measurements

All infants wirth high risk of cp will be assessed by neuroimaging and Hammersmith Neonatal Neurological Examination (HNNE) at term age, Prechtl's General movements (GMs) assessments form birth up to 3-5 months, and will be assesed by Hammersmith Infant Neurological Examination (HINE) at 2,3,6,9 and 12th months, also BAYLEY-III Infant and Toddler Development Assessment Scale (BAYLEY-III) at the 3rd, 6th, and 12th months.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Measurements of neurological development.

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Weeks
• Maximum Eligible Age: 42 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role: lead

Responsible Party

Hatice Adiguzel

Assistant Proffessor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

hatice adıgüzel, PhD

Role: PRINCIPAL_INVESTIGATOR

Kahramanmaras Sutcu Imam University

Locations

Hatice Adiguzel

Kahramanmaraş, Dulkadiroglu, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KSU1

Identifier Type: -

Identifier Source: org_study_id