Etiology, Prevention and Treatment of Neonatal Infections in the Community
Etiology, Prevention, and Treatment of Neonatal Infections in the Community
1 other identifier
interventional
16,359
1 country
1
Brief Summary
The purpose of this study is to determine what are the major types of bacteria that cause newborn infections in the community in rural Bangladesh and whether providing an obstetric and neonatal care package will reduce neonatal deaths by 40%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2003
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedApril 20, 2018
April 1, 2018
3.8 years
September 12, 2005
April 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Health workers will visit households at three month intervals for 18 months and survey the status of the babies.
Secondary Outcomes (1)
At anytime during the study, if the baby shows symptoms of serious infection, the health worker will offer advice on where to go for treatment, or offer to treat the baby at home.
Interventions
Eligibility Criteria
You may qualify if:
- pregnant women (any age)
- newborns
You may not qualify if:
- children (outside newborn period)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dhaka Shishu Hospital
Dhaka, Bangladesh
Related Publications (3)
Darmstadt GL, Baqui AH, Choi Y, Bari S, Rahman SM, Mannan I, Ahmed AS, Saha SK, Seraji HR, Rahman R, Winch PJ, Chang S, Begum N, Black RE, Santosham M, Arifeen SE; Bangladesh Projahnmo-2 (Mirzapur) Study. Validation of a clinical algorithm to identify neonates with severe illness during routine household visits in rural Bangladesh. Arch Dis Child. 2011 Dec;96(12):1140-6. doi: 10.1136/archdischild-2011-300591. Epub 2011 Sep 30.
PMID: 21965811DERIVEDDarmstadt GL, Choi Y, Arifeen SE, Bari S, Rahman SM, Mannan I, Seraji HR, Winch PJ, Saha SK, Ahmed AS, Ahmed S, Begum N, Lee AC, Black RE, Santosham M, Crook D, Baqui AH; Bangladesh Projahnmo-2 Mirzapur Study Group. Evaluation of a cluster-randomized controlled trial of a package of community-based maternal and newborn interventions in Mirzapur, Bangladesh. PLoS One. 2010 Mar 24;5(3):e9696. doi: 10.1371/journal.pone.0009696.
PMID: 20352087DERIVEDDarmstadt GL, Saha SK, Choi Y, El Arifeen S, Ahmed NU, Bari S, Rahman SM, Mannan I, Crook D, Fatima K, Winch PJ, Seraji HR, Begum N, Rahman R, Islam M, Rahman A, Black RE, Santosham M, Sacks E, Baqui AH; Bangladesh Projahnmo-2 (Mirzapur) Study Group. Population-based incidence and etiology of community-acquired neonatal bacteremia in Mirzapur, Bangladesh: an observational study. J Infect Dis. 2009 Sep 15;200(6):906-15. doi: 10.1086/605473.
PMID: 19671016DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gary Darmstadt, MD
Johns Hopkins Bloomberg School of Public Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
December 1, 2003
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
April 20, 2018
Record last verified: 2018-04