This trial is active, not recruiting.

Conditions bacterial infection, infectious disease
Treatment co-trimoxazole; tmp-smz
Sponsor Johns Hopkins Bloomberg School of Public Health
Start date December 2003
End date September 2007
Trial size 16359 participants
Trial identifier NCT00198627, H.


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%.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Health workers will visit households at three month intervals for 18 months and survey the status of the babies.
time frame:

Secondary Outcomes

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.
time frame:

Eligibility Criteria

Male or female participants at least 1 month old.

Inclusion Criteria: - pregnant women (any age) - newborns Exclusion Criteria: - children (outside newborn period)

Additional Information

Official title Etiology, Prevention, and Treatment of Neonatal Infections in the Community
Principal investigator Gary Darmstadt, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2007.
Information provided to ClinicalTrials.gov by Johns Hopkins Bloomberg School of Public Health.