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Community Based Interventions to Reduce Neonatal Mortality in Bangladesh

Primary Purpose

Infectious Disease

Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Improved management of severe neonatal infections
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infectious Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: participants consenting for the home-based care model area participants who consent for household adequacy survey participants who consent from clinic care model area

Sites / Locations

  • ICDDR,B

Outcomes

Primary Outcome Measures

Neonatal mortality rate

Secondary Outcome Measures

Neonatal colonization with antibiotic-resistant bacteria
Cost of providing the intervention services per neonate

Full Information

First Posted
September 12, 2005
Last Updated
September 12, 2014
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh, Shimantik, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT00198705
Brief Title
Community Based Interventions to Reduce Neonatal Mortality in Bangladesh
Official Title
Community Based Interventions to Reduce Neonatal Mortality in Bangladesh
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh, Shimantik, Bangladesh

4. Oversight

5. Study Description

Brief Summary
This project delivers, promotes and facilitates services related to pregnancy, delivery and newborn care.
Detailed Description
The Project entitled "Community-Based Intervention to Reduce Neonatal Mortality in Bangladesh", also known as Projahnmo - I (Project to Advance the Health of Newborns and Mothers), is a partnership project of the Johns Hopkins Bloomberg School of Public Health (JHSPH), USA, with a number of Bangladeshi organizations including: a) the Ministry of Health and Family Welfare (MOHFW) of the Government of Bangladesh (GoB), b) the Centre for Health and Population Research (ICDDRB), c) Save the Children/USA, Bangladesh Field Office (SC/BFO), d) Shimantik, a Bangladeshi NGO, e) BRAC/Bangladesh, f) Dhaka Shishu Hospital and g) the Institute of Child and Mother Health (ICMH). The project is funded through four mechanisms: 1) USAID Global funding to cover expenses of JHSPH to design and to provide technical assistance in the implementation and evaluation of the various components of the project, 2) SNL/SC funding to JHSPH to sub-contract the Bangladeshi institutions listed above to support implementation of the intervention component of the project, 3) USAID/Bangladesh funding to ICDDRB to cover the cost of implementation of the research and evaluation component of the project, 4) the Bangladeshi government's contribution in-terms of staff time, supplies, and facilities. This partnership between multiple research institutions and donors brings diverse, rich and unique experiences and expertise. It ensures the relevance of the project and increases the likelihood of scaling up and sustaining the intervention. The goals of Projahnmo I are to: (a) introduce two models of delivering improved maternal and newborn care in rural Bangladesh; (b) measure each model's impact on neonatal mortality and other relevant indicators; (c) assess the cost effectiveness and feasibility of the two models. The project includes two intervention arms with two different service delivery models, home care (HC) and clinic care (CC). Community health workers (CHWs) and community mobilizers (CMs) deliver the Birth and Newborn Care Preparedness (BNCP) package, which includes counseling during the antenatal period, delivery care, care of the baby during delivery, postnatal care, and continued counseling and education during the neonatal period. Service provision also includes making referral for sick newborns and playing the role of facilitator for behavior change in the households and communities. The strategic approaches used also include pregnancy surveillance and community-level mobilization of specific target groups, such as pregnant women, senior female family members, husbands and other targeted local advocacy meetings. In both arms, community-based meetings conducted by CMs focus on facilitating involvement of the mothers and other family members in the decision-making process and making them aware of the importance of proper antenatal care, delivery care, postpartum care, and newborn care. In the HC model, counseling is conducted at home with pregnant women and their families by CHWs. In the CC arm, women receive these messages through community meetings by CMs and during antenatal check-up (ANC) visits by governmental primary health workers and paramedics. In CC arms, CMs identify community change agents to assist in creating awareness and promoting behavior change. In addition, traditional birth attendants (TBAs), who commonly attend home deliveries in the study communities, have been oriented on newborn health.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10670 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Improved management of severe neonatal infections
Primary Outcome Measure Information:
Title
Neonatal mortality rate
Secondary Outcome Measure Information:
Title
Neonatal colonization with antibiotic-resistant bacteria
Title
Cost of providing the intervention services per neonate

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: participants consenting for the home-based care model area participants who consent for household adequacy survey participants who consent from clinic care model area
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdullah Baqui
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICDDR,B
City
Dhaka
Country
Bangladesh

12. IPD Sharing Statement

Citations:
PubMed Identifier
19684100
Citation
Baqui AH, Ahmed S, El Arifeen S, Darmstadt GL, Rosecrans AM, Mannan I, Rahman SM, Begum N, Mahmud AB, Seraji HR, Williams EK, Winch PJ, Santosham M, Black RE; Projahnmo 1 Study Group. Effect of timing of first postnatal care home visit on neonatal mortality in Bangladesh: a observational cohort study. BMJ. 2009 Aug 14;339:b2826. doi: 10.1136/bmj.b2826.
Results Reference
derived
PubMed Identifier
18539225
Citation
Baqui AH, El-Arifeen S, Darmstadt GL, Ahmed S, Williams EK, Seraji HR, Mannan I, Rahman SM, Shah R, Saha SK, Syed U, Winch PJ, Lefevre A, Santosham M, Black RE; Projahnmo Study Group. Effect of community-based newborn-care intervention package implemented through two service-delivery strategies in Sylhet district, Bangladesh: a cluster-randomised controlled trial. Lancet. 2008 Jun 7;371(9628):1936-44. doi: 10.1016/S0140-6736(08)60835-1.
Results Reference
derived

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Community Based Interventions to Reduce Neonatal Mortality in Bangladesh

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