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The EPICS Trial: Enabling Parents to Increase Child Survival
DOI 10.1186/ISRCTN52433336
ClinicalTrials.gov identifier
EudraCT number
Public title The EPICS Trial: Enabling Parents to Increase Child Survival
Scientific title The EPICS Trial: Enabling Parents to Increase Child Survival - a cluster randomised controlled trial
Acronym EPICS
Serial number at source 1000
Study hypothesis The aim of the trial is to assess whether an intervention package that includes community health promotion campaign and education through health clubs, intensive training and mentoring of village health workers to diagnose and provide first-line treatment for children's diseases within the community, and improved outreach services can generate a rapid and cost-effective reduction in under-five child mortality in rural regions of Guinea-Bissau.
Lay summary Not provided at time of registration
Ethics approval 1. Ministry of Health, Bissau, Guinea-Bissau, approved on the 13th June 2007 (ref: 021/2007)
2. London School of Hygiene and Tropical Medicine, UK, approved on the 3rd October 2007 (ref: 5173)
Study design Cluster randomised controlled trial
Countries of recruitment Guinea-Bissau
Disease/condition/study domain Child mortality
Participants - inclusion criteria 146 clusters were chosen in Quinara and Tombali.

1. Inclusion criteria for mothers:
Women enumerated during a baseline survey aged between 12 and 49 years
2. Inclusion criteria for children:
2.1. Both males and females, five years of age or younger
2.2. Children born after randomisation, or born after the baseline survey
2.3. Alive at the time of randomisation
Participants - exclusion criteria Does not meet inclusion criteria
Anticipated start date 01/09/2007
Anticipated end date 01/10/2010
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 11,400 children and their mothers
Interventions This is a cluster randomised controlled trial involving 146 clusters. The trial will run for 2.5 years.

Intervention group: community health clubs, trained village health workers, community provision of medicines, and mobile clinics
Control group: standard care

Intervention personnel will assist anyone in Emergencies. Controls will benefit from the training of health staff at clinics.
Primary outcome measure(s) The proportion of children that die during the study period. Outcomes assessed until 1st October 2010.
Secondary outcome measure(s) 1. Neonatal, infant and maternal mortality rates
2. Age at and cause of child deaths
3. Treatment practices for sick children
4. Mother's or primary carer's health knowledge
5. Deliveries conducted at institutions or with a trained assistant
6. Indicators of safe birthing practices

Outcomes assessed until 1st October 2010.
Sources of funding Effective Intervention (UK)
Trial website
Publications 1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19650919
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21888632
Contact name Dr  Peter  Boone
  Address London School of Economics
Centre for Economic Performance
  City/town London
  Zip/Postcode W2 1SP
  Country United Kingdom
Sponsor Effective Intervention (UK)
  Address c/o Dr Peter Boone
London School of Economics
Centre for Economic Performance
Houghton Street
  City/town London
  Zip/Postcode W2 1SP
  Country United Kingdom
  Sponsor website: http://www.effint.org/
Date applied 13/05/2009
Last edited 17/01/2012
Date ISRCTN assigned 09/06/2009
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