Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00518596
Status:
COMPLETED
Last Update Posted:
2017-06-15
First Post:
2007-08-20
Brief Title:
Prevention of Infection in Indian Neonates - Phase II Probiotics Study
Sponsor:
NICHD Global Network for Womens and Childrens Health
Organization:
NICHD Global Network for Womens and Childrens Health
Study Overview
Official Title:
Prevention of Infection in Indian Neonates - Phase II Probiotics Study
Status:
COMPLETED
Status Verified Date:
2017-06
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:
India with one of the worlds largest populations continues to struggle with extremely high infant and neonatal mortality rates Neonatal infection sepsis now accounts for 50 percent of deaths among community-born and 20 percent of mortality among hospital-born infants This study is the first phase of a multi-phase project investigating interventions to prevent neonatal infection in India
Detailed Description:
Phase II is a hospital based intervention n 297 infants measuring the colonizing ability safety and tolerance of a probiotic supplement Lactobacillus plantarum in the neonatal gut Newborn infants 35 weeks of gestation will be randomized to receive either L plantarum preparations containing 109 organisms or placebo preparations orally once a day for the first 7 days of life The final stage of the project will be a community-based randomized double-blind placebo-controlled trial of L plantarum enrolling over 8000 newborns to examine the efficacy of probiotic supplementation in reducing neonatal infection in Indian neonates
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 |
|---|---|---|---|
| R01HD053719 | NIH | None | httpsreporternihgovquickSearchR01HD053719 |
| U01HD040574 | NIH | None | None |