Clinical trial NCT05217186: Associations Between Early Neonatal Neuroimaging, Hammersmith Infant Neurological Examination and General Movements
Official title: Associations Between Early Neonatal Neuroimaging, Hammersmith Infant Neurological Examination and General Movements Assessment in a Cohort of High Risk of Infants: One Year Follow Up
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Keywords: Neonatal Neuroimaging
Hammersmith Infant Neurological Evaluation (HINE)
General Movements (GMs)
High Risk of Infants
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 63
Sex: ALL
Minimum age (years): 25
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: High risk of infants for cerebral palsy.

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.

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.

Primary outcomes:
measure: Neonatal Magnetic Resonance Imaging (MRI)
timeFrame: at term age of infants (40 weeks), one assesment
measure: Hammersmith Neonatal Neurological Examination (HNNE)
timeFrame: at term age of infants (40 weeks), one assesment
measure: Hammersmith Infant Neurological Examination (HINE)
timeFrame: Change from the baseline of the HINE score at 2, 3, 6, 9,12th month of infants
measure: The Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III)
timeFrame: Change from the baseline of the BAYLEY-III score at 3, 6,12th month of infants
measure: General Movement Assessment (GMs)1
timeFrame: Measurement at preterm age (birth to 40weeks)
measure: General Movement Assessment (GMs)2
timeFrame: Measurement between the term age to 9th weeks
measure: General Movement Assessment (GMs)3
timeFrame: Measurement at fidgety periods of life (between 10th weeks to 20th weeks)
Secondary outcomes:
measure: demographic information1
timeFrame: first day of birth
measure: demographic information2
timeFrame: first day of birth
Other outcomes:
Locations:
city: Kahramanmaras
country: Turkey
facility: Hatice Adiguzel
state: Dulkadiroglu
Study officials:
affiliation: Kahramanmaras Sutcu Imam University
name: hatice adıgüzel, PhD
role: PRINCIPAL_INVESTIGATOR
References: