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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00006516 |
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.
Condition | Intervention | Phase |
---|---|---|
Hypoxia, Brain Hypoxia-Ischemia, Brain |
Behavioral: Infant stimulation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Neuroplasticity of Brain-Asphyxiated Infants: Efficacy of Intervention |
Estimated Enrollment: | 120 |
Study Start Date: | September 1999 |
Estimated Study Completion Date: | August 2004 |
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.
Ages Eligible for Study: | up to 1 Month |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
All of the following criteria must be met:
Two or more of the following must be met:
Exclusion Criteria:
Contact: Meena Garg, MD | 310-794-8864 | mgarg@mednet.ucla.edu |
United States, California | |
University of California at Los Angeles | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: Meena Garg, MD 310-794-8864 mgarg@mednet.ucla.edu |
Principal Investigator: | Meena Garg, MD | University of California at Los Angeles |
Study ID Numbers: | NICHD-0115, 1R01 HD38600-01 |
Study First Received: | November 21, 2000 |
Last Updated: | November 2, 2006 |
ClinicalTrials.gov Identifier: | NCT00006516 |
Health Authority: | United States: Federal Government |
Neonatal brain injury Brain Hypoxia Cerebral Hypoxia Brain Hypoxia-Ischemia Brain Ischemia-Hypoxia Cerebral Hypoxia-Ischemia |
Cerebral Ischemia-Hypoxia Environmental enrichment Cognitive/sensorimotor stimulation Parent-infant interactions Prenatal hypoxia |
Cerebral Infarction Hypoxia, Brain Vascular Diseases Central Nervous System Diseases Ischemia Brain Diseases Cerebrovascular Disorders |
Anoxia Signs and Symptoms Hypoxia-Ischemia, Brain Brain Ischemia Signs and Symptoms, Respiratory Brain Injuries |
Pathologic Processes Nervous System Diseases Cardiovascular Diseases |