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Etiology, Prevention and Treatment of Neonatal Infections in the Community

This study is ongoing, but not recruiting participants.
Study NCT00198627.   Last updated on April 23, 2007.   Information provided by Johns Hopkins Bloomberg School of Public Health

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Descriptive Information Fields
Brief Title  Etiology, Prevention and Treatment of Neonatal Infections in the Community
Official Title  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%.

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.
Study Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Primary Outcome Measure  Health workers will visit households at three month intervals for 18 months and survey the status of the babies.
Secondary Outcome Measure  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.
Condition  Bacterial Infection
Infectious Disease
Intervention  Drug: Co-Trimoxazole; TMP-SMZ
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  16359
Start Date  December 2003
Completion Date September 2007
Eligibility Criteria 

Inclusion Criteria:

  • pregnant women (any age)
  • newborns

Exclusion Criteria:

  • children (outside newborn period)
Gender Both
Ages 1 Month and older
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  Bangladesh
Administrative Information Fields
NCT ID  NCT00198627
Organization ID H.22.01.09.05.A1
Secondary IDs ††
Study Sponsor  Johns Hopkins Bloomberg School of Public Health
Collaborators ††
Investigators 
Principal Investigator:     Gary Darmstadt, MD     Johns Hopkins Bloomberg School of Public Health    
Information Provided By Johns Hopkins Bloomberg School of Public Health
Verification Date April 2007
First Received Date  September 12, 2005
Last Updated Date April 23, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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