Hypoxia-Ischemia, Brain Clinical Trial
Official title:
Neuroplasticity of Brain-Asphyxiated Infants: Efficacy of Intervention
This study examines the potential benefits of a home stimulation program to treat infants who have suffered from brain asphyxiation (lack of oxygen). The program involves one year of stimulatory activities. Progress will be evaluated through neurological and behavioral exams.
Although the incidence of brain injury in infants is only 2 to 5 per 1000 births, the legal
and medical costs, the developmental delays, and the impact on the family are profound.
Twenty to 30% of survivors of brain injury have some long-term neurologic sequelae.
This randomized controlled trial will enroll 120 term and near-term neonates with a history
of asphyxia to 1-year of a standard follow-up program (provided by the Los Angeles Regional
Centers) or a home-based intervention program (Utah State University's Developmental
Curriculum and Monitoring System, CAMS). The experimental intervention will include
individualized cognitive/neuromotor stimulation given by the child's parents under the
guidance of public health nurses. Following the intervention, measures will be used to
determine functional capacity (Bayley II scale and neurologic examination), behavioral
outcomes (HOME and NCAST by developmental specialists), and maternal outcomes (including
parent-infant interaction and perceived stress). Infants will be assessed after the 1-year
intervention by psychologists and physicians masked to the intervention. Functional MRI
brain studies will be conducted at discharge and 18 months of age at UCLA to assess
qualitative and quantitative sensorimotor representation. Secondary outcomes include care
stress and social support as reported by parents, and demographics and medical factors
obtained from the hospital records.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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