Community interventions to increase child survival in Nepal

ISRCTN	ISRCTN87820538
DOI	https://doi.org/10.1186/ISRCTN87820538
Protocol serial number	N/A
Sponsor	University College London (UCL) Centre for International Health and Development (UK)
Funder	UBS Optimus Foundation (Switzerland)

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

Primary study design	Interventional
Study design	Factorial cluster randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/01/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	12000
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

United Kingdom
England
Nepal

Study participating centre

UCL Centre for International Health and Development

London
WC1N 1EH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results on prevalence of Caesarean section	30/12/2014	30/12/2020	Yes	No
Protocol article	protocol	03/06/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

30/12/2020: Publication reference added.