Etiology, Prevention and Treatment of Neonatal Infections in the Community

• Sponsor: Johns Hopkins Bloomberg School of Public Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT00198627
• Collaborator: (none)
• Enrollment: 16,359
• Location: 1
• Duration (Months): 45
• Patients Per Site Per Month: 363.5

Study Details

Study Description

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%.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Infection; Infectious Disease	Drug: Co-Trimoxazole; TMP-SMZ	N/A

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Etiology, Prevention, and Treatment of Neonatal Infections in the Community
• Study Start Date: Dec 1, 2003
• Actual Primary Completion Date: Sep 1, 2007
• Actual Study Completion Date: Sep 1, 2007

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Month and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• pregnant women (any age)

• newborns

Exclusion Criteria:

• children (outside newborn period)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dhaka Shishu Hospital	Dhaka		Bangladesh

Sponsors and Collaborators

• Johns Hopkins Bloomberg School of Public Health

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00198627
• Other Study ID Numbers: H.22.01.09.05.A1
• First Posted: Sep 20, 2005
• Last Update Posted: Apr 20, 2018
• Last Verified: Apr 1, 2018

• Keywords provided by , ,: Neonatal bacterial infection
• Additional relevant MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Trimethoprim, Sulfamethoxazole Drug Combination

Study Results

No Results Posted as of Apr 20, 2018