Ignite Creation Date:
2024-05-05 @ 9:26 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004392
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Incidence and Severity of Cardiorespiratory Events in Infants at Increased Epidemiological Risk for Sudden Infant Death Syndrome SIDS
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-01
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:
OBJECTIVES I Assess and compare the incidence and severity of cardiorespiratory events documented by home monitoring in infants at increased epidemiological risk for sudden infant death syndrome SIDS
II Determine the antecedent medical demographic physiologic and behavioral characteristics that predict the incidence of cardiorespiratory events documented by home monitoring
II Determine the antecedent medical demographic physiologic and behavioral characteristics that predict the incidence of cardiorespiratory events documented by home monitoring
Detailed Description:
PROTOCOL OUTLINE This is a multicenter collaborative study Patients are stratified into 4 groups healthy term infants apnea of infancy subsequent siblings of SIDS victims and preterm infants
The caregivers are trained in the use of home monitor equipment and in the graded response to monitor alarms observation gentle stimulation more vigorous stimulation mouth to mouth breathing and full cardiopulmonary resuscitation
Caregivers undergo infant cardiopulmonary resuscitation CPR training not required for caregivers of healthy term infants
Demographic information is obtained on each infant A 30 second recording of each infants cry is performed at study entry and at 1 month corrected age and at the polysomnogram A urine sample is collected and frozen
The CHIME monitor is used during sleep and whenever the infant is not being observed
An overnight polysomnography is performed within 2 weeks of study entry At 1 25 6 and 12 months corrected age infants participate in a clinical evaluation Neurodevelopmental status is assessed at 1 4 and 12 months corrected age
The caregivers are trained in the use of home monitor equipment and in the graded response to monitor alarms observation gentle stimulation more vigorous stimulation mouth to mouth breathing and full cardiopulmonary resuscitation
Caregivers undergo infant cardiopulmonary resuscitation CPR training not required for caregivers of healthy term infants
Demographic information is obtained on each infant A 30 second recording of each infants cry is performed at study entry and at 1 month corrected age and at the polysomnogram A urine sample is collected and frozen
The CHIME monitor is used during sleep and whenever the infant is not being observed
An overnight polysomnography is performed within 2 weeks of study entry At 1 25 6 and 12 months corrected age infants participate in a clinical evaluation Neurodevelopmental status is assessed at 1 4 and 12 months corrected age
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| YALESM-CHIME-HD9102 | None | None | None |