Etiology, Prevention and Treatment of Neonatal Infections in the Community

Infectious Disease Clinical Trial

Official title:

Etiology, Prevention, and Treatment of Neonatal Infections in the Community

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00198627
• Other study ID #: H.22.01.09.05.A1
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: April 18, 2018
• Start date: December 2003
• Est. completion date: September 2007

Study information

• Verified date: April 2018
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16359
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month and older

Eligibility

Inclusion Criteria:

• pregnant women (any age)

• newborns

Exclusion Criteria:

• children (outside newborn period)

Related Conditions & MeSH terms

• Bacterial Infection
• Bacterial Infections
• Communicable Diseases
• Infection
• Infectious Disease

Intervention

Drug:
• Co-Trimoxazole; TMP-SMZ

Locations

Country	Name	City	State
Bangladesh	Dhaka Shishu Hospital	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health workers will visit households at three month intervals for 18 months and survey the status of the babies.
Secondary	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.