Etiology, Prevention and Treatment of Neonatal Infections in the Community

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 Overview

• Status: Completed
• Conditions: Infectious Disease; Bacterial Infection
• Intervention / Treatment: Drug: Co-Trimoxazole; TMP-SMZ

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.

• Study Type: Interventional
• Enrollment: 16359
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh
    • Dhaka Shishu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• pregnant women (any age)
• newborns

Exclusion Criteria:

• children (outside newborn period)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Investigators: Principal Investigator: Gary Darmstadt, MD, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

General Publications

• Darmstadt GL, Baqui AH, Choi Y, Bari S, Rahman SM, Mannan I, Ahmed AS, Saha SK, Seraji HR, Rahman R, Winch PJ, Chang S, Begum N, Black RE, Santosham M, Arifeen SE; Bangladesh Projahnmo-2 (Mirzapur) Study. Validation of a clinical algorithm to identify neonates with severe illness during routine household visits in rural Bangladesh. Arch Dis Child. 2011 Dec;96(12):1140-6. doi: 10.1136/archdischild-2011-300591. Epub 2011 Sep 30.
• Darmstadt GL, Choi Y, Arifeen SE, Bari S, Rahman SM, Mannan I, Seraji HR, Winch PJ, Saha SK, Ahmed AS, Ahmed S, Begum N, Lee AC, Black RE, Santosham M, Crook D, Baqui AH; Bangladesh Projahnmo-2 Mirzapur Study Group. Evaluation of a cluster-randomized controlled trial of a package of community-based maternal and newborn interventions in Mirzapur, Bangladesh. PLoS One. 2010 Mar 24;5(3):e9696. doi: 10.1371/journal.pone.0009696.
• Darmstadt GL, Saha SK, Choi Y, El Arifeen S, Ahmed NU, Bari S, Rahman SM, Mannan I, Crook D, Fatima K, Winch PJ, Seraji HR, Begum N, Rahman R, Islam M, Rahman A, Black RE, Santosham M, Sacks E, Baqui AH; Bangladesh Projahnmo-2 (Mirzapur) Study Group. Population-based incidence and etiology of community-acquired neonatal bacteremia in Mirzapur, Bangladesh: an observational study. J Infect Dis. 2009 Sep 15;200(6):906-15. doi: 10.1086/605473.

Study record dates

Study Major Dates

• Study Start: December 1, 2003
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Actual): April 20, 2018
• Last Update Submitted That Met QC Criteria: April 18, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Neonatal bacterial infection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Bacterial Infections; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Anti-Infective Agents, Urinary; Renal Agents; Trimethoprim, Sulfamethoxazole Drug Combination
• Other Study ID Numbers: H.22.01.09.05.A1