Etiology, Prevention and Treatment of Neonatal Infections in the Community
Information source: Johns Hopkins Bloomberg School of Public Health
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacterial Infection; Infectious Disease
Intervention: Co-Trimoxazole; TMP-SMZ (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Johns Hopkins Bloomberg School of Public Health Official(s) and/or principal investigator(s):
Gary Darmstadt, MD, Principal Investigator, Affiliation: Johns Hopkins Bloomberg School of Public Health
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%.
Clinical Details
Official title: Etiology, Prevention, and Treatment of Neonatal Infections in the Community
Study design: Treatment, Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Primary outcome: Health workers will visit households at three month intervals for 18 months and survey the status of the babies.
Secondary outcome: 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.
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
Minimum age: 1 Month.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- pregnant women (any age)
- newborns
Exclusion Criteria:
- children (outside newborn period)
Locations and Contacts
Dhaka Shishu Hospital, Dhaka, Bangladesh
Additional Information
Starting date: December 2003
Ending date: September 2007
Last updated: April 23, 2007
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