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| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | April 23, 2007 | ||||
| Start Date ICMJE | December 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Health workers will visit households at three month intervals for 18 months and survey the status of the babies. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00198627 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Etiology, Prevention and Treatment of Neonatal Infections in the Community | ||||
| Official Title ICMJE | Etiology, Prevention, and Treatment of Neonatal Infections in the Community | ||||
| 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%. |
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| Detailed Description | 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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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Co-Trimoxazole; TMP-SMZ | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 16359 | ||||
| Estimated Completion Date | September 2007 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 1 Month and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Bangladesh | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00198627 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | H.22.01.09.05.A1 | ||||
| Study Sponsor ICMJE | Johns Hopkins Bloomberg School of Public Health | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Johns Hopkins Bloomberg School of Public Health | ||||
| Verification Date | April 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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