Implementing knowledge into practice for improved neonatal survival: a community-based trial in Quang Ninh province, Vietnam

ISRCTN	ISRCTN44599712
DOI	https://doi.org/10.1186/ISRCTN44599712
Secondary identifying numbers	N/A

Submission date: 07/05/2008
Registration date: 07/07/2008
Last edited: 18/12/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Neonatal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Uwe Ewald
Scientific

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

Study information

Study design	Single-centre cluster-randomised population-based community intervention trial
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	Community
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Implementing knowledge into practice for improved neonatal survival: a cluster-randomised, community-based trial in Quang Ninh province, Vietnam
Study acronym	NeoKIP
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	02/06/2008
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	300000
Key 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.
Key exclusion criteria	Districts in Quang Ninh province with a NMR less than 15/1000 were excluded.
Date of first enrolment	02/06/2008
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

Sweden
Viet Nam

Study participating centre

University Hospital

Uppsala
75185
Sweden

Sponsor information

Swedish Agency for International Development Cooperation (Sida)/Department for Research Cooperation (SAREC) (Sweden)
Government

Valhallavägen 199
Stockholm
10525
Sweden

Website	http://www.sida.se
"ROR"	https://ror.org/01fn7me06

Funders

Funder type

Government

Swedish Agency for International Development Cooperation (Sida)/Department for Research Cooperation (SAREC) (Sweden)

No information available

Uppsala Universitet
Government organisation / Universities (academic only)

Alternative name(s): Uppsala University, UU_University, Uppsala Universitet, Sweden, UU
Location: Sweden

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	results	28/03/2008		Yes	No
Results article	results	01/03/2011		Yes	No
Other publications	study design	27/09/2011		Yes	No
Results article	results	01/04/2012		Yes	No
Results article	results	01/12/2012		Yes	No
Results article	results	01/12/2013		Yes	No
Results article	results	29/12/2015		Yes	No
Results article	results	13/01/2016		Yes	No
Results article	results	01/09/2018	18/12/2019	Yes	No

Editorial Notes

18/12/2019: Publication reference added.
04/07/2016: Publication reference added.
15/01/2016: Publication reference added.