Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A cluster randomised controlled trial of the impact of community women's groups and sepsis management by community volunteers on newborn survival and maternal and infant nutrition
Acronym
MIRA Dhanusha
Study hypothesis
1. A participatory intervention with women's groups will be associated with reductions in perinatal and neonatal mortality
2. Work by women's groups on dietary issues will be associated with improvements in maternal and infant nutrition, and possibly in perinatal and neonatal mortality
3. Training of community volunteers in the recognition and management of neonatal sepsis will be associated with increases in identification and treatment of neonatal sepsis, and improvements in neonatal mortality
Ethics approval
1. Nepal Health Research Council Ethics Committee (Nepal) gave approval on the 25th November 2004
2. Ethics Committee of the Institute of Child Health and Great Ormond Street Hospital for Children (UK) gave approval on the 14th March 2005
Study design
Factorial cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Neonatal mortality; neonatal sepsis
Intervention
This is a factorial cluster randomised controlled trial involving 60 village development committee clusters.
Female Community Health Volunteers will be supported in convening monthly women's groups. The groups will work through an action research cycle in which they:
1. Identify local issues around maternity, newborn health and nutrition
2. Prioritise key problems
3. Develop strategies to address them
4. Implement the strategies
5. Evaluate their success
Female Community Health Volunteers will be trained to care for vulnerable newborn infants. They will:
1. Identify local births
2. Identify low birth weight infants
3. Identify possible newborn infection
4. Manage the process of treatment and referral
5. Follow up infants and support families
Total duration of treatment: 2 years. Total duration of follow-up: 3 years.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Neonatal mortality rates. Outcome measures are collected prospectively on an ongoing basis, so no specific timepoints for measurement. However, for the purposes of analysis of the trial, we will look at both primary and secondary outcome measures annually for 3 years.
Secondary outcome measures
1. Community groups:
1.1. Care practices and health care seeking behaviour
2. Stillbirth rates
3. Maternal mortality ratios
2. Sepsis management:
2.1. Identification and treatment of neonatal sepsis by community health volunteers
2.2. Causes of death assessed by community verbal autopsy
Outcome measures are collected prospectively on an ongoing basis, so no specific timepoints for measurement. However, for the purposes of analysis of the trial, we will look at both primary and secondary outcome measures annually for 3 years.
Overall trial start date
01/01/2008
Overall trial end date
01/01/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Main target population:
1. Women of reproductive age, of whom there are 140,000
2. Infants under a year of age, of whom there are 19,000
3. 26,000 pregnancies expected annually in the district
Key participants:
Women who either join community groups or have a pregnancy. The women's group intervention involves social mobilisation and group membership and activities will not be restricted to women of reproductive age. Since the aim is to improve the situation of pregnant women and their newborn infants, any participant who may affect this situation may be involved. Particular stakeholders may be older women, male community members, health workers and local opinion formers. All women and their newborn infants will be eligible to participate in the data collection exercise, for which enrolment will occur either during pregnancy or in the post-natal period.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
100 births per cluster per year, giving 200 births in 2 years and 12000 births in total.
Participant exclusion criteria
Does not meet the inclusion criteria
Recruitment start date
01/01/2008
Recruitment end date
01/01/2010
Locations
Countries of recruitment
Nepal
Trial participating centre
UCL Centre for International Health and Development
London
WC1N 1EH
United Kingdom
Sponsor information
Organisation
University College London (UCL) Centre for International Health and Development (UK)
Sponsor details
c/o Professor Anthony Costello
30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 (0)20 7905 2261
a.costello@ich.ucl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
UBS Optimus Foundation (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. protocol in http://www.ncbi.nlm.nih.gov/pubmed/21635791
Publication citations
-
Protocol
Shrestha BP, Bhandari B, Manandhar DS, Osrin D, Costello A, Saville N, Community interventions to reduce child mortality in Dhanusha, Nepal: study protocol for a cluster randomized controlled trial., Trials, 2011, 12, 136, doi: 10.1186/1745-6215-12-136.