Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Implementing knowledge into practice for improved neonatal survival: a cluster-randomised, community-based trial in Quang Ninh province, Vietnam
Acronym
NeoKIP
Study hypothesis
The overall objective of this project is to evaluate if facilitation on the community level results in effective improvement of perinatal health and survival. Specifically, we hypothesise:
1. That a cluster-randomised intervention using a facilitation approach targeting primary health care staff and key community members reduces the risk for neonatal death, and
2. That the facilitation intervention will result in increased knowledge and use of evidence-based practice related to maternal and perinatal health among health care staff in intervention as compared to the control clusters
Ethics approval
1. The Ministry of Health (Vietnam), 12/10/2007, ref: 3934/QD-BYT
2. The Provincial Health Bureau in Quang Ninh (Vietnam)
3. The Research Ethics Committee at Uppsala University (Sweden), 25/01/2006, ref: 2005:319
Study design
Single-centre cluster-randomised population-based community intervention trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Community
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Neonatal health and survival
Intervention
The facilitation intervention targets CHC staff and key persons at the community level. Each CHC is accountable for the health care in the community, including all villages. For each village the CHC has one Village Health Worker (VHW) who is responsible for the basic health care. At each CHC, there are 3 - 6 staff working, of whom a midwife or a medical doctor provides perinatal care. Key persons in the community are the vice chairman and the Women Union leader, who both are in decision-making positions. The basic feature of the study intervention is that individuals from the Women Union are acting as facilitators in supporting CHC staff and key persons in their efforts to improve health care practice. Individuals from local Women Union organisations have been recruited and trained for one week to be able to act as facilitators. A locally recruited person act as supervisor of the facilitators; i.e., supporting the facilitators, assisting and coordinating in the facilitation process, and report back to the research team.
A facilitation manual was developed to guide the work of the facilitators. Each facilitator operates within the same communities for the whole intervention period and meet with each community group monthly. Such a group, called the Maternal-Newborn-Health-Group (MNHG), normally consists of three CHC staff, a village health worker, the vice chairman in the community and two women union representatives (community and village level). The facilitator uses a problem solving, participatory and enabling approach (instead of prescribing and directing a set of actions). Basing the discussions on individual and common experiences, the facilitator support critical reflection, problem identification, finding solutions, setting up and accomplish change strategies, using the PLAN-DO-STUDY-ACT cycle. This intervention implies a strong local ownership and 'bottom-up' approach in empowering health care staff to improve practice. As an ingredient in the facilitation strategy, the recommendations in the National Guidelines are highlighted. Practically the work process entails the development of an action plan at one meeting to be fully or partial implemented until next meeting, where the process proceeds.
The unit of intervention (and thus randomisation) is the community with its Community Health Centre, and will be proportional to the number of deliveries in the communities. Approximately 44 communities will be allocated to the intervention arm of the study.
Controls are communities without intervention.
The total duration of the intervention will be two years. Follow-up will be done three years after the end of intervention.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Neonatal mortality, measured one year after intervention start and at the end of intervention (two years)
Secondary outcome measures
1. Effects on home visits by midwifes
2. Exclusive breast-feeding
3. Temperature control
4. Knowledge among health staff
5. Care-seeking behaviour
6. Other indicators for neonatal health
Outcomes will be measured one year after intervention start and at the end of intervention (two years).
Overall trial start date
02/06/2008
Overall trial end date
31/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Districts in Quang Ninh province in Northern Vietnam with a neonatal mortality rate (NMR) higher than 15/1000 have been selected for the intervention, resulting in a study involving eight districts composed by 87 communities with a corresponding community health centre (CHC). In 2005 there were 6227 births and 150 neonatal deaths in these districts resulting in a NMR of 24/1000.
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
300000
Participant exclusion criteria
Districts in Quang Ninh province with a NMR less than 15/1000 were excluded.
Recruitment start date
02/06/2008
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Viet Nam
Trial participating centre
University Hospital
Uppsala
75185
Sweden
Sponsor information
Organisation
Swedish Agency for International Development Cooperation (Sida)/Department for Research Cooperation (SAREC) (Sweden)
Sponsor details
Valhallavägen 199
Stockholm
10525
Sweden
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Swedish Agency for International Development Cooperation (Sida)/Department for Research Cooperation (SAREC) (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Uppsala Universitet
Alternative name(s)
Uppsala University
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Sweden
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18373839
2. 2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20958789
3. 2011 study design in: http://www.ncbi.nlm.nih.gov/pubmed/21951770
4. 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22107114
5. 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23153956
6. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23690755
7. 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26713871
8. 2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26762125
Publication citations
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Results
Målqvist M, Eriksson L, Nguyen TN, Fagerland LI, Dinh PH, Wallin L, Ewald U, Persson LA, Unreported births and deaths, a severe obstacle for improved neonatal survival in low-income countries; a population based study., BMC Int Health Hum Rights, 2008, 8, 4, doi: 10.1186/1472-698X-8-4.
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Results
Målqvist M, Nga NT, Eriksson L, Wallin L, Hoa DP, Persson LÅ, Ethnic inequity in neonatal survival: a case-referent study in northern Vietnam., Acta Paediatr., 2011, 100, 3, 340-346, doi: 10.1111/j.1651-2227.2010.02065.x.
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Study design
Wallin L, Målqvist M, Nga NT, Eriksson L, Persson LÅ, Hoa DP, Huy TQ, Duc DM, Ewald U, Implementing knowledge into practice for improved neonatal survival; a cluster-randomised, community-based trial in Quang Ninh province, Vietnam., BMC Health Serv Res, 2011, 11, 239, doi: 10.1186/1472-6963-11-239.
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Results
Nga NT, Hoa DT, Målqvist M, Persson LÅ, Ewald U, Causes of neonatal death: results from NeoKIP community-based trial in Quang Ninh province, Vietnam., Acta Paediatr., 2012, 101, 4, 368-373, doi: 10.1111/j.1651-2227.2011.02513.x.
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Results
Hoa DT, Börjesson L, Nga NT, Johansson A, Målqvist M, Sex of newborns associated with place and mode of delivery: a population-based study in northern Vietnam., Gend Med, 2012, 9, 6, 418-423, doi: 10.1016/j.genm.2012.10.010.
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Results
Persson LÅ, Nga NT, Målqvist M, Thi Phuong Hoa D, Eriksson L, Wallin L, Selling K, Huy TQ, Duc DM, Tiep TV, Thi Thu Thuy V, Ewald U, Effect of Facilitation of Local Maternal-and-Newborn Stakeholder Groups on Neonatal Mortality: Cluster-Randomized Controlled Trial., PLoS Med., 2013, 10, 5, e1001445, doi: 10.1371/journal.pmed.1001445.
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Results
L Eriksson, TQ Huy, DM Duc, KE Selling, DP Hoa, NT Thuy, NT Nga, L-Å Persson, L Wallin, Process evaluation of a knowledge translation intervention using facilitation of local stakeholder groups to improve neonatal survival in the Quang Ninh province, Vietnam, Trials, 2016, 17, 1, 23, doi: 10.1186/s13063-015-1141-z.
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Results
Målqvist M, Hoa DP, Persson LÅ, Ekholm Selling K, Effect of Facilitation of Local Stakeholder Groups on Equity in Neonatal Survival; Results from the NeoKIP Trial in Northern Vietnam, PLoS One, 2015, 10, 12, e0145510, doi: 10.1371/journal.pone.0145510.