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| Sponsor: | Johns Hopkins Bloomberg School of Public Health |
|---|---|
| Information provided by: | Johns Hopkins Bloomberg School of Public Health |
| ClinicalTrials.gov Identifier: | NCT00198627 |
Purpose
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%.
| Condition | Intervention |
|---|---|
|
Bacterial Infection Infectious Disease |
Drug: Co-Trimoxazole; TMP-SMZ |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Etiology, Prevention, and Treatment of Neonatal Infections in the Community |
| Estimated Enrollment: | 16359 |
| Study Start Date: | December 2003 |
| Estimated Study Completion Date: | September 2007 |
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:
Eligibility| Ages Eligible for Study: | 1 Month and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Bangladesh | |
| Dhaka Shishu Hospital | |
| Dhaka, Bangladesh | |
| Principal Investigator: | Gary Darmstadt, MD | Johns Hopkins Bloomberg School of Public Health |
More Information
| ClinicalTrials.gov Identifier: | NCT00198627 History of Changes |
| Other Study ID Numbers: | H.22.01.09.05.A1 |
| Study First Received: | September 12, 2005 |
| Last Updated: | April 23, 2007 |
| Health Authority: | United States: Institutional Review Board; Dhaka, Bangladesh: ICDDR,B Research Review and Ethical Review Committee; Dhaka Bangladesh: Dhaka Shishu Hospital IRB; United Kingdom: Oxford University IRB |
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Neonatal bacterial infection |
|
Bacterial Infections Communicable Diseases Infection Trimethoprim-Sulfamethoxazole Combination Anti-Infective Agents, Urinary Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Renal Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents |