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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%.
The study seeks answers to two questions:
Despite significant decline in infant and child mortality rates in recent decades, neonatal mortality rates remain unacceptably high. Of the 8 million infant deaths that occur worldwide each year, approximately 4 million occur in the neonatal period.
Hence, the specific aims of the study include:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Co-Trimoxazole; TMP-SMZ | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Health workers will visit households at three month intervals for 18 months and survey the status of the babies. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Darmstadt, MD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dhaka Shishu Hospital | Dhaka | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21965811 | Derived | 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. | |
| 20352087 |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| ID | Term |
|---|---|
| D013420 | Sulfamethoxazole |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
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| Derived |
| Darmstadt 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. |
| 19671016 | Derived | Darmstadt 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014295 | Trimethoprim |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |