Official Title: “Etiology, Prevention, and Treatment of Neonatal Infections in the Community”

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%.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Co-Trimoxazole; TMP-SMZ

Primary Measures

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

Secondary 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.

Inclusion Criteria:

• pregnant women (any age)
• newborns

Exclusion Criteria:

• children (outside newborn period)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 1 Month

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Overall Clinical Trial Officials and Contacts

Gary Darmstadt, MD Principal Investigator Johns Hopkins Bloomberg School of Public Health  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00198627

Study ID Number: H.22.01.09.05.A1

ClinicalTrials.gov Identifier: NCT00198627

Health Authority: United States: Institutional Review Board