Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006516
Status:
COMPLETED
Last Update Posted:
2016-09-26
First Post:
2000-11-21
Brief Title:
Home Stimulation for Brain-Asphyxiated Infants
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Neuroplasticity of Brain-Asphyxiated Infants Efficacy of Intervention
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 Universitys Developmental Curriculum and Monitoring System CAMS The experimental intervention will include individualized cognitiveneuromotor stimulation given by the childs 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
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 Universitys Developmental Curriculum and Monitoring System CAMS The experimental intervention will include individualized cognitiveneuromotor stimulation given by the childs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HD038600-01 | NIH | None | httpsreporternihgovquickSearch1R01HD038600-01 |