- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00198705
Community Based Interventions to Reduce Neonatal Mortality in Bangladesh
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Dhaka, Bangladesh
- Icddr,b
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Neonatal mortality rate
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Neonatal colonization with antibiotic-resistant bacteria
|
|
Cost of providing the intervention services per neonate
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H.22.00.12.06.BX
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infectious Disease
-
Centre de Recherche Médicale de LambarénéNot yet recruitingTropical Infectious Disease
-
Shaare Zedek Medical CenterTerminatedInfectious Disease TransmissionIsrael
-
The Third Xiangya Hospital of Central South UniversitySANSURE BIOTECH INC.UnknownInfectious Disease ScreeningChina
-
The Hong Kong Polytechnic UniversityCompletedInfectious Disease TransmissionHong Kong
-
CerbaXpertRecruiting
-
Carecubes, Inc.University of NebraskaCompletedInfectious DiseasesUnited States
-
King Saud Medical CityUnknown
-
BayerCompletedInfectious DiseasesItaly
-
Universidad de GuanajuatoAntisepsia CentralCompleted
-
LG Life SciencesCompleted
Clinical Trials on Improved management of severe neonatal infections
-
St. Justine's HospitalCanadian Blood ServicesUnknownLymphoproliferative DisordersCanada
-
Assiut UniversityNot yet recruitingSeizures | Neonatal Convulsions | Newborn Seizure Disorders
-
Complejo Hospitalario Dr. Arnulfo Arias MadridCompletedPreeclampsiaEcuador, Guatemala, Mexico, Panama, Peru, Venezuela
-
Peking University Third HospitalUnknownSevere MalnutritionChina
-
International Centre for Diarrhoeal Disease Research...UNICEF; UBS Optimus FoundationUnknownPneumonia ChildhoodBangladesh
-
Nanjing Medical UniversityShandong Provincial Hospital; Northwest Women's and Children's Hospital, Xi... and other collaboratorsCompletedHyperbilirubinemia, Neonatal | Quality ImprovementChina
-
Surgical Systems Research GroupWellcome Trust; Tropical Institute of Community HealthActive, not recruiting
-
Hospices Civils de LyonRecruitingCampylobacter InfectionsFrance
-
CHU de Quebec-Universite LavalRecruitingImmunoglobulins in Multiple Myeloma Patients Receiving a BCMA-Directed T Cell Engager (CHUQUL_HO001)Relapsed Multiple Myeloma | Multiple Myeloma RefractoryCanada