Community interventions to increase child survival in Nepal

ISRCTN ISRCTN87820538
DOI https://doi.org/10.1186/ISRCTN87820538
Secondary identifying numbers N/A
Submission date
11/03/2009
Registration date
25/06/2009
Last edited
30/12/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Anthony Costello
Scientific

UCL Centre for International Health and Development
30 Guilford Street
London
WC1N 1EH
United Kingdom

Study information

Study designFactorial cluster randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA 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
Study acronymMIRA Dhanusha
Study objectives1. 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(s)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
Health condition(s) or problem(s) studiedNeonatal mortality; neonatal sepsis
InterventionThis 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 typeOther
Primary outcome measureNeonatal 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 measures1. 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 study start date01/01/2008
Completion date01/01/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants100 births per cluster per year, giving 200 births in 2 years and 12000 births in total.
Key inclusion criteriaMain 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.
Key exclusion criteriaDoes not meet the inclusion criteria
Date of first enrolment01/01/2008
Date of final enrolment01/01/2010

Locations

Countries of recruitment

  • England
  • Nepal
  • United Kingdom

Study participating centre

UCL Centre for International Health and Development
London
WC1N 1EH
United Kingdom

Sponsor information

University College London (UCL) Centre for International Health and Development (UK)
University/education

c/o Professor Anthony Costello
30 Guilford Street
London
WC1N 1EH
England
United Kingdom

Phone +44 (0)20 7905 2261
Email a.costello@ich.ucl.ac.uk
Website http://www.ucl.ac.uk/cihd/
ROR logo "ROR" https://ror.org/02jx3x895

Funders

Funder type

Research organisation

UBS Optimus Foundation (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 03/06/2011 Yes No
Results article results on prevalence of Caesarean section 30/12/2014 30/12/2020 Yes No

Editorial Notes

30/12/2020: Publication reference added.