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Etiology, Prevention and Treatment of Neonatal Infections in the Community

This study is ongoing, but not recruiting participants.

Sponsored by: 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

MedlinePlus related topics:   Bacterial Infections   

ChemIDplus related topics:   Trimethoprim-sulfamethoxazole combination   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:   Etiology, Prevention, and Treatment of Neonatal Infections in the Community

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Health workers will visit households at three month intervals for 18 months and survey the status of the babies.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment:   16359
Study Start Date:   December 2003
Estimated Study Completion Date:   September 2007

Detailed Description:

The study seeks answers to two questions:

  1. What are the major bacterial pathogens responsible for serious neonatal infections in the community in rural Bangladesh?
  2. Can provision of a package of obstetric and neonatal care, including active surveillance for serious neonatal illness and referral to hospital, and identification of barriers to care-seeking and design of strategies to address them reduce neonatal mortality rates by at least 40% compared to communities in which such services are not provided?

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:

  1. identifying the principal agents of serious bacterial infections in Bangladeshi neonates in the community
  2. evaluating the impact of introducing a package of essential obstetric and neonatal care practices in the community, including identifying barriers to care-seeking and design of strategies to address those barriers and
  3. building capacity within Bangladesh by training Bangladeshi scientists in epidemiological and microbiological techniques, clinical research methods and best clinical practice through an on-going collaboration with Dhaka Shishu (Children) Hospital and the International Centre for Diarrhoeal Disease Research, Bangladesh.
  Eligibility
Ages Eligible for Study:   1 Month and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • pregnant women (any age)
  • newborns

Exclusion Criteria:

  • children (outside newborn period)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198627

Locations
Bangladesh
Dhaka Shishu Hospital    
      Dhaka, Bangladesh

Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health

Investigators
Principal Investigator:     Gary Darmstadt, MD     Johns Hopkins Bloomberg School of Public Health    
  More Information

Study ID Numbers:   H.22.01.09.05.A1
First Received:   September 12, 2005
Last Updated:   April 23, 2007
ClinicalTrials.gov Identifier:   NCT00198627
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

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Neonatal bacterial infection  

Study placed in the following topic categories:
Bacterial Infections
Trimethoprim
Sulfamethoxazole
Trimethoprim-Sulfamethoxazole Combination

Additional relevant MeSH terms:
Antimalarials
Anti-Infective Agents
Communicable Diseases
Antiparasitic Agents
Antiprotozoal Agents
Therapeutic Uses
Anti-Infective Agents, Urinary
Renal Agents
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2008




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