Neonatal Sepsis, Evaluation, Bangladesh
NCT01333982 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20000
Last updated 2014-10-30
Summary
More than half of under-five deaths in Bangladesh occur in the first month of life (neonatal period), and a substantial proportion of these deaths are due to infections (sepsis). According to the recently formulated Bangladesh National Neonatal Health Strategy (NNHS), the Government of Bangladesh is committed to improve access to quality management of neonatal infections. The strategy emphasizes that health service providers at all levels acquire the skills for managing sepsis.
Responding to the recommendations in the National Neonatal Health Strategy, this operations research seeks to evaluate alternative approaches for the management of neonatal sepsis in the community. The evaluation will focus on assessing intervention coverage, provider quality of care, and referral and referral compliance, and will undertake cost-benefit analysis of community-based neonatal sepsis management. The programme and evaluation will be within the existing health service delivery system in Bangladesh and is thus designed to inform the effective scaling up of neonatal sepsis management and contribute to the implementation of the NNHS. The interventions to be evaluated will be nested in the Maternal, Neonatal and Child Survival (MNCS) programme being implemented by the Government of Bangladesh, in partnership with and supported by UNICEF, and several national NGOs.
This operations research is being implemented by the Government of Bangladesh in collaboration with UNICEF, SNL - Save the Children (USA), Bangladesh Perinatal Society, and ICDDR,B. It will take place in four MNCS programme upazilas, where 10 unions will be randomly selected for intervention and 10 unions will be comparison. The intervention consists of training of community health workers, village doctors and health facility workers on managing neonatal sepsis in addition to essential newborn care training. In the comparison areas the health workers will only receive essential newborn care training.
The intervention and evaluation will continue for at least 18 months, with rolling surveys and two special surveys at 6 and 12 months into the project. The rolling surveys will look at intervention coverage, care-seeking, and referral and referral compliance, while the two special surveys will assess provider performance, referral compliance, and quality of care. In addition, the investigators will document implementation processes to understand what worked and what did not and why.
Conditions
Interventions
- OTHER
-
Amoxycillin, Gentamicin
If referral fails, community management of neonatal sepsis according to clinical algorithm.
- OTHER
-
Counselling
counselling of management of neonatal sepsis in the community according to clinical algorithm.
Sponsors & Collaborators
-
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
collaborator OTHER -
Johns Hopkins Bloomberg School of Public Health
collaborator OTHER -
International Centre for Diarrhoeal Disease Research, Bangladesh
lead OTHER
Principal Investigators
-
Shams El Arifeen, MBBS, DrPh · International Centre for Diarrhoeal Disease Research, Bangladesh
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Max Age
- 2 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-04-30
- Primary Completion
- 2013-12-31
- Completion
- 2013-12-31
Countries
- Bangladesh
Study Locations
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