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Completed

NCT Number: NCT00198627

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%.

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Key information

Age range

1 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dhaka Shishu Hospital

Dhaka, Bangladesh

About this study

The study seeks answers to two questions:

  • What are the major bacterial pathogens responsible for serious neonatal infections in the community in rural Bangladesh?
  • 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:

  • identifying the principal agents of serious bacterial infections in Bangladeshi neonates in the community
  • 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
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pregnant women (any age)
  • newborns

Exclusion criteria

  • children (outside newborn period)

Treatment and study plan

Co-Trimoxazole; TMP-SMZ

Drug

Primary outcomes

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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Sep 20, 2005
Registry last updated
Apr 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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