Clinical trial NCT00198627: Etiology, Prevention and Treatment of Neonatal Infections in the Community
Official title: Etiology, Prevention, and Treatment of Neonatal Infections in the Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Infection
Infectious Disease
Keywords: Neonatal bacterial infection
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 16359
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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%.

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 criteria: Inclusion Criteria:

* pregnant women (any age)
* newborns

Exclusion Criteria:

* children (outside newborn period)

Primary outcomes:
measure: Health workers will visit households at three month intervals for 18 months and survey the status of the babies.
Secondary outcomes:
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.
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Dhaka Shishu Hospital
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Gary Darmstadt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.