Impact of a community-based participatory intervention to improve essential newborn care (ENC) in rural Nepal: a randomised controlled trial

ISRCTN	ISRCTN31137309
DOI	https://doi.org/10.1186/ISRCTN31137309
Secondary identifying numbers	98-CH-06

Submission date: 04/06/2004
Registration date: 02/07/2004
Last edited: 10/09/2007

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

Study website

Contact information

Prof Anthony Costello
Scientific

30 Guilford Street
London
WC1N 1EH
United Kingdom

Phone	+44 (0)20 7905 2261
Email	ipu@ich.ucl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Scientific title
Study acronym	MIRA (Mother and Infant Research Activities - a Nepali non-governmental organisation [NGO]) Makwanpur Study
Study objectives	Neonatal deaths in developing countries make the largest contribution to global mortality in children younger than 5 years. 90% of deliveries in the poorest quintile of households happen at home. We postulated that a community-based participatory intervention could significantly reduce neonatal mortality rates.
Ethics approval(s)	The study was approved by the Nepal Health Research Council and the ethics committee of the Institute of Child Health and Great Ormond Street Hospital for Children.
Health condition(s) or problem(s) studied	Neonatal mortality
Intervention	12 local female facilitators work within VDCs in the Makwanpur District in Nepal to explore perinatal health issues, with one in each of the 12 intervention VDCs. Their role is to act as a change agent rather than a teacher, to activate and strengthen existing mothers' groups, support them in identifying and prioritising maternal and neonatal problems, help to identify possible solutions and support the planning, implementation and monitoring of the solution strategies in the community. Each women's group moves through a participatory planning cycle of assessment, sharing experiences, planning, action and reassessment with the aim of improving essential maternal and newborn care. We have also trained women identified by local community groups as baby monitors to spot high risk newborn infants soon after birth. The study will compare outcomes including neonatal and perinatal mortality rates, perinatal care practices and health service utilisation in 12 village development committee areas (8,000 people per VDC), compared with 12 matched areas where the intervention is not implemented. Married women of reproductive age (15-49 years) within the study area have been identified and are visited monthly by study personnel. All pregnancies occurring within the cohort will be followed until at least six weeks after delivery to determine the outcome of birth.
Intervention type	Other
Primary outcome measure	Neonatal mortality rate
Secondary outcome measures	1. Stillbirths and maternal deaths 2. Uptake of antenatal and delivery services 3. Home care practices 4. Infant morbidity 5. Health-care seeking
Overall study start date	01/09/1999
Completion date	01/11/2000

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	24 village development committees
Key inclusion criteria	Married women aged 15 to 49 in 24 rural Village Development Committees (VDCs) in Makwanpur District, Nepal
Key exclusion criteria	No exclusion criteria
Date of first enrolment	01/09/1999
Date of final enrolment	01/11/2000

Locations

Countries of recruitment

England
Nepal
United Kingdom

Study participating centre

30 Guilford Street

London
WC1N 1EH
United Kingdom

Sponsor information

Institute of Child Health (UK)
Research organisation

30 Guilford Street
London
WC1N 1EH
United Kingdom

Website	http://www.ich.ucl.ac.uk/
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Research organisation

Department for International Development (DFID)

No information available

The Department of Child and Adolescent Health and Development (CAH)/World Health Organization (WHO) (Switzerland)

No information available

United Nations Children's Fund (UNICEF)

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?
Results article		11/09/2004		Yes	No
Other publications		15/06/2006		Yes	No