Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00518856
Status:
COMPLETED
Last Update Posted:
2011-03-31
First Post:
2007-08-20
Brief Title:
Lufwanyama Neonatal Survival Project
Sponsor:
Boston University
Organization:
Boston University
Study Overview
Official Title:
Lufwanyama Neonatal Survival Project
Status:
COMPLETED
Status Verified Date:
2011-03
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:
LUNESP
Brief Summary:
We seek to determine whether we can reduce day 28 mortality in Zambian newborns by training traditional birth attendants a modified version of the neonatal resuscitation protocol NRP and by improving their abiltiy to identify sepsis and initiate antibiotics in the field
Detailed Description:
This is a cluster randomized trial of the impact of providing additional training and supplies to traditional birth attendants in a rural setting in Zambia 120 TBAs are randomized into interventioncontrol Intervention TBAs receive NRP training supplies for neonatal resuscitation receiving blankets for thermoregulation and amoxicillin tablets Control TBAs continue according to prior standard of care Primary outcome is mortality at 28 days life as a proportion of births attended by TBAs in each study arm
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