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
Scientific
UCL Centre for International Health and Development
30 Guilford Street
London
WC1N 1EH
United Kingdom
Study information
| Study design | Factorial cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | MIRA Dhanusha |
| Study objectives | 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(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) studied | 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 |
| 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 study start date | 01/01/2008 |
| Completion date | 01/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 100 births per cluster per year, giving 200 births in 2 years and 12000 births in total. |
| Key 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. |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 01/01/2010 |
Locations
Countries of recruitment
- England
- Nepal
- United Kingdom
Study participating centre
UCL Centre for International Health and Development
London
WC1N 1EH
United Kingdom
WC1N 1EH
United Kingdom
Sponsor information
University College London (UCL) Centre for International Health and Development (UK)
University/education
University/education
c/o Professor Anthony Costello
30 Guilford Street
London
WC1N 1EH
England
United Kingdom
| Phone | +44 (0)20 7905 2261 |
|---|---|
| a.costello@ich.ucl.ac.uk | |
| Website | http://www.ucl.ac.uk/cihd/ |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
