Condition category
Neonatal Diseases
Date applied
07/05/2008
Date assigned
07/07/2008
Last edited
04/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Uwe Ewald

ORCID ID

Contact details

Department of Women's and Children's Health
University Hospital
Uppsala
75185
Sweden

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

http://www.sida.se

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Additional files

Editorial Notes

04/07/2016: Publication reference added. 15/01/2016: Publication reference added.