Design, Implementation and Assessment of a Comprehensive Community Neonatal Heath Package Utilising Medical and Social Interventions
Phase: NA
Conditions: Perinatal Mortality
Sponsor: University of Oxford

 
 
 
 
Study Title:  Design, implementation and assessment of a comprehensive 
community neonatal heath package utilising medical and social interventions 
 
Short title: Saving Babies Lives 
 
Date and Version No: 11th July 2022, Version 6.0 
 
Trial registration number: NCT04663620 
 
 
 

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Study Title:  Design, implementation and assessment of a comprehensive community neonatal 
heath package utilising medical and social interventions 
 
Internal Reference Number / Short title: Saving Babies Lives  
 
Date and Version No: 11th July 2022, Version 6.0 
 
Chief Investigator: 
Dr Claudia Turner (Research Paediatrician, COMRU / MORU; CEO 
Angkor Hospital for Children) 
Email: claudia@tropmedres.ac 
Phone: +85595839729 
 
Dr Sopheakneary Say (Saving Babies Lives Programme, Angkor 
Hospital for Children) 
Email: sopheakneary@angkorhospital.org 
Phone: +85512404007 
 
Ms Daly Leng (Saving Babies Lives Programme, Angkor Hospital 
for Children) 
Email: daly@angkorhospital.org 
Phone: +85512657242 
 
Investigators:  
Dr Kaajal Patel (Research Paediatrician, COMRU / MORU; Saving 
Babies Lives Programme, Angkor Hospital for Children;  
Email: kaajal@angkorhospital.org 
Phone: +85517240282 
 
Dr Arthur Riedel (Saving Babies Lives Programme, Angkor Hospital 
for Children) 
Email: riedel@angkorhospital.org 
Phone: +85561981501 
 
Dr Koung Lo (Director of Provincial Health Department, Preah 
Vihear Province) 
Email: kounglo@yahoo.com 
Phone: +85512892909 
 
 
Sponsor:  
University of Oxford, UK 
Funder: 
Angkor Hospital for Children 
Chief Investigator 
Signature:  
 
 
 
 
 

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The Chief Investigators have no conflicts of interest to declare 
 
Sponsor: 
University of Oxford 
OxTREC reference: 
547-17 
NECHR reference: 
283 NECHR 
MORU 
HCR17009 
 
Confidentiality Statement 
This document contains confidential information that must not be disclosed to anyone other than the 
authorised individuals from the University of Oxford, the Investigator Team and members of the Oxford 
Tropical Research Ethics Committee (OxTREC), unless authorised to do so. 
 
 

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TABLE OF CONTENTS 
 
1. 
SYNOPSIS ............................................................................................................................................... 5 
2. 
ABBREVIATIONS ..................................................................................................................................... 7 
3. 
BACKGROUND AND RATIONALE ............................................................................................................ 8 
3.1. 
Research Question......................................................................................................................... 9 
3.2. 
Intervention ................................................................................................................................... 9 
Saving Babies Lives Programme ............................................................................................................ 9 
Neonatal Mortality .............................................................................................................................. 11 
Economic Evaluation ........................................................................................................................... 11 
3.3. 
Study Site ..................................................................................................................................... 12 
4. 
OBJECTIVES AND OUTCOME MEASURES ............................................................................................. 12 
5. 
STUDY DESIGN ..................................................................................................................................... 14 
6. 
PARTICIPANT IDENTIFICATION AND RECRUITMENT ........................................................................... 15 
6.1. 
Saving Babies Lives Training Programme .................................................................................... 15 
6.2. 
Study Participants ........................................................................................................................ 15 
6.3. 
Inclusion Criteria .......................................................................................................................... 15 
6.4. 
Exclusion Criteria ......................................................................................................................... 15 
6.5. 
VHSG Baby Health Meetings ....................................................................................................... 15 
6.6. 
Study Participants ........................................................................................................................ 15 
6.7. 
Inclusion Criteria .......................................................................................................................... 15 
6.8. 
Exclusion Criteria ......................................................................................................................... 15 
7. 
STUDY PROCEDURES ........................................................................................................................... 15 
7.1. 
Saving Babies Lives Programme .................................................................................................. 15 
7.2. 
Recruitment ................................................................................................................................. 15 
7.3. 
Screening and Eligibility Assessment ........................................................................................... 15 
7.4. 
Informed Consent ........................................................................................................................ 15 
7.5. 
Discontinuation/Withdrawal of Participants from Study ............................................................ 16 
7.6. 
VHSG Baby Health Meetings ....................................................................................................... 16 
7.7. 
Recruitment ................................................................................................................................. 16 
7.8. 
Informed Consent ........................................................................................................................ 16 
7.9. 
Discontinuation/Withdrawal of Participants from Study ............................................................ 16 
8. 
STATISTICS AND ANALYSIS ................................................................................................................... 16 
8.1. 
Description of Statistical Methods .............................................................................................. 16 
9. 
DATA MANAGEMENT .......................................................................................................................... 18 

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9.1. 
Access to Data ............................................................................................................................. 18 
9.2. 
Data sharing ................................................................................................................................. 18 
9.3. 
Data Handling and Record Keeping ............................................................................................. 19 
10. 
QUALITY CONTROL AND QUALITY ASSURANCE PROCEDURES ........................................................ 19 
11. 
ETHICAL AND REGULATORY CONSIDERATIONS ............................................................................... 19 
11.1. 
Declaration of Helsinki............................................................................................................. 19 
11.2. 
Guidelines for Good Clinical Practice ...................................................................................... 19 
11.3. 
Approvals ................................................................................................................................. 19 
11.4. 
Participant Confidentiality ....................................................................................................... 19 
11.5. 
Expenses and Benefits ............................................................................................................. 20 
11.6. 
Reporting ................................................................................................................................. 20 
12. 
FINANCE AND INSURANCE .............................................................................................................. 20 
12.1. 
Funding .................................................................................................................................... 20 
12.2. 
Insurance ................................................................................................................................. 20 
13. 
PUBLICATION POLICY ....................................................................................................................... 20 
14. 
REFERENCES .................................................................................................................................... 21 
15. 
Appendices ...................................................................................................................................... 23 
 
 
 

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1. SYNOPSIS 
 
Study Title 
Design, implementation and assessment of a comprehensive community 
neonatal heath package utilising medical and social interventions 
Internal ref. no.  
N/A 
Study Design 
Cluster randomised control trial 
Study Participants 
The population of Preah Vihear (PVH) province, Cambodia 
Planned Sample Size 
 293 villages with 586 Village Health Support Group Workers (VHSG) 
 26,500 children born in Preah Vihear over the study period and their 
parents (5,300 deliveries a year) 
 306 health centre nurses and midwives from 28 health centres and 17 
health posts in Preah Vihear  
 30 nurses, 27 midwives and 18  doctors from Preah Vihear Referral 
Hospital  
Planned Study Period 
5 years 
 
Objectives 
Outcome Measures 
Primary 
 
The design, implementation and 
assessment of a comprehensive 
community neonatal heath package 
utilising medical and social 
interventions 
A comprehensive community 
neonatal heath package utilising 
medical and social interventions 
Secondary 
 
Reduction of perinatal mortality in 
PVH province, Cambodia 
A one third reduction in perinatal 
mortality in PVH province, 
Cambodia 
Tertiary 
To describe the characteristics of 
neonates, born in PVH province, 
Cambodia over a five-year time period 
A document that describes the 
characteristics of neonates, born in 
PVH province, Cambodia over a 
five-year time period 
 
To develop a tool to undertake a full 
review of neonatal services and 
capabilities in PVH province, 
Cambodia 
A user-friendly tool to assess 
neonatal healthcare services 
A report detailing neonatal 
services and capabilities in PVH 
province, Cambodia 
 
Design a fully comprehensive neonatal 
healthcare training and 
implementation package adapted to 
local need 
A locally appropriate neonatal 
healthcare training and 
implementation package 
 
Establish regular VHSG meetings  to 
address areas of concern for the local 
community with respect to childbirth 
and the neonatal period 
Frequency and attendance rate of 
participants at the programmes 
VHSG group meetings 

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With the Kingdom of Cambodia, 
Ministry of Health and the Provincial 
Health Director of PVH province 
develop a programme blueprint and 
implementation strategy for 
introduction of the developed 
programme into other locations 
within Cambodia 
A programme and implementation 
plan for the reduction of neonatal 
mortality that can be used 
throughout Cambodia 
 
To calculate the cost-effectiveness of 
a neonatal community health 
programme and the resulting changes 
in care, as compared to the existing 
care given in the region 
A cost effectiveness analysis 
 
 
 
 

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2. ABBREVIATIONS 
 
AHC 
Angkor Hospital for Children 
CI 
Chief Investigator 
COMRU 
Cambodia Oxford Medical Research Unit 
CRF 
Case Report Form 
GCP 
Good Clinical Practice 
HC 
Health Centre 
HP 
Health Post 
KAP 
Knowledge, Attitudes and Practice 
KAPES 
Knowledge, Attitudes, Practice, Equipment and Staff 
NMR 
Neonatal mortality rate 
OxTREC 
Oxford Tropical Research Ethics Committee 
PAR 
Participatory Action Research 
PI 
Principal Investigator 
PIS 
Participant Information Sheet 
PVH 
Preah Vihear 
SBLP 
Saving Babies Lives Programme 
SBLT 
Saving Babies Lives Team 
VHSG 
Village Health Support Group 
 
 

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3. BACKGROUND AND RATIONALE 
Globally the proportion of childhood deaths that occur in the neonatal period is increasing [1]. Since 1990 
there has been a 47% reduction in deaths in children less than five years of age [2]. However, this rate of 
reduction has not been seen in infants four weeks of age or younger (neonates). It is estimated that 2.9 
million neonates die each year, with one million of these occurring on the first day of life [3]. Neonatal 
mortality now makes up 44% of all deaths in children younger than five years [3]. The reasons why the fall 
in neonatal mortality has not mirrored that seen in children mortality, is complex and one that is not well 
explored in the literature.  
Cambodia has met most targets of the 4th and 5th Millennium Development Goals, reducing child mortality 
and improving maternal health by investing in health systems [4, 5]. However, the Sustainable 
Development Goals call for further improvements and Cambodia continues to fall behind its neighbouring 
countries in reducing neonatal mortality [6]. 
One proposed explanation is that interventions that have been successfully employed to reduce childhood 
death do not reach the community and it is in the community where most neonates die [7, 8]. Another 
pervasive perceived barrier to providing neonatal care, particularly in remote and rural areas, is the 
misconception that neonatal care is difficult and expensive [9]. 
During the neonatal period, perhaps more than at any other time, there are deep rooted health practices 
and beliefs. These differ in different communities but often share common themes. Hot bed use, food 
avoidance in the mother postpartum, discarding colostrum and application of various substances to the 
umbilical cord (such as cow dung, petrol and ash) are examples of widely held practices [10-12]. Many of 
these practices are potentially harmful to the neonate and need to be addressed in the communities where 
they occur by community engagement and education. 
Community 
Many health problems are rooted in powerlessness. Health education that involves community 
involvement: dialogue and problem solving, rather than just message giving, is more empowering.  
Addressing social needs and empowering communities to make decisions about health care needs allows 
for the design of programmes that account for local practices and beliefs [13, 14]. In participatory action 
research (PAR) communities identify and prioritise problems, develop action plans, implement these plans 
and assess them [15-18]. Community assessment of health problems and barriers increases the awareness 
of those problems; it has been shown to increase social support and participation in problem solving [13]. 
PAR uses facilitation rather than teaching to increase knowledge in community groups. 
Health Care facilities 
Up to two-thirds of neonatal deaths could be prevented if neonates were given proper care during and 
immediately after birth, because the majority of neonatal deaths occur around the time of delivery [19]. 
Training primary level health care workers to deal with emergency situations that occur around the time 
of delivery, such as ante-partum and post-partum haemorrhage, umbilical cord prolapse and shoulder 
dystocia, has been shown to decrease maternal mortality and neonatal mortality [20]. Similarly, a model 
for neonatal care in low-resource settings, special baby care areas, has been proven to significantly reduce 
neonatal mortality over a period of a few years [9].  
It is reported that 79% of deliveries in Cambodia occur in healthcare facilities [21]. The majority of these 
will occur at primary healthcare facilities (health centres (HC) or health Posts (HP)). Babies born in HCs or 

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HPs who require further care are referred to the referral hospital. The majority of referral hospitals in 
Cambodia do not have the resources or skills to effectively deal with neonatal complications for babies 
born either in health centres or in their on-site maternity wards.  
The Saving Babies Lives Programme will be developed in partnership with the Kingdom of Cambodia 
Ministry of Health (MoH). The programme will be approved by the MoH and a memorandum of 
understanding signed with the provincial health director of Preah Vihear (PVH) province. The major 
objective of this project is to develop a programme blueprint and implementation strategy for introduction 
of the developed programme into other locations within Cambodia. Data will be collected and used to 
assess the impact of the programme, its perceived facilitators and barriers and its successes and failures. 
This information will be used to iterate the programme content and structure in order to improve it. 
3.1. Research Question  
The central hypothesis of this study is that a neonatal healthcare programme that has a significant impact 
on neonatal mortality and which spans the healthcare journey from village to referral hospital can be 
developed and implemented in low resource rural setting 
Aim of the study 
The design, implementation and assessment of a comprehensive community neonatal heath package 
utilising medical and social interventions 
3.2. Intervention 
The study has four components 
1. Design and implementation of a locally appropriate comprehensive neonatal healthcare package 
– Saving Babies Lives Programme (SBLP) 
2. Establishment of  baby health meetings for VHSGs 
3. Measurement of perinatal mortality in PVH province 
4. Economic evaluation of the programme and its implementation 
 
Saving Babies Lives Programme 
A comprehensive, contextual and adaptive neonatal healthcare package will be developed using the 
Kingdom of Cambodia national guidelines on neonatal and maternal health, WHO maternal and child 
health guidelines and results from the pre-implementation assessment [24-26]. Course-based training will 
be combined with continuous in-situ mentoring to support doctors, nurses and midwives and other health 
worker cadres in order to improve their practical daily skills in emergency and clinical neonatal care. 
Essential equipment will be identified and included in the package. The neonatal healthcare package will 
be developed by the Saving Babies Lives team which consists of experienced nursing and medical staff 
working at the Angkor Hospital for Children (AHC), Cambodia. AHC is a non-governmental teaching hospital 
that has been in operation since 1999. Each year it provides approximately 180,000 free treatments to 
neonates and children and has a dedicated neonatal care programme. 
A neonatal healthcare assessment tool will be developed that is quantitative and qualitative in nature. It 
will be based on the KAP survey method of analysing Knowledge, Attitudes and Practice. KAP involves a 
representative survey on a specific topic, of a particular population, by using predefined questions in 
standardised questionnaires, to produce data which may be quantitative, qualitative, or a mixture of the 

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two [27, 28]. In addition, two further domains will be added, equipment and staffing, leading to a “KAPES” 
model of assessment. Before the neonatal healthcare package is introduced into a HC or HP the KAPES 
assessment will be carried out. It will also be performed after the initial training period and then annually 
until the end of the study. The information gathered using this tool will further inform the content of the 
neonatal health care package. 
VHSG Baby Health Meetings  
Baby Health meetings (BHM) will be conducted at each HC. Each BHM will be attended by two VHSG from 
each of the villages served by the HC. The purpose of the BHM is to identify problems and concerns around 
neonatal health care in their own village. Monthly meetings will take place at the HC in order for the group 
to discuss problems, attempt to arrive at solutions, and share learning. These meetings will be facilitated 
by the SBL team who will use a Participatory Action Research (PAR) methodology to: 
1. Identify problems with provision of, and barriers to seeking, neonatal health care 
2. Develop interventions to improve care 
3. Implement these interventions  
4. Assess the group’s perception of the effectiveness of interventions (Figure 1).  
Specific questions and prompts will be devised by the SBLT prior to the meeting and will be based on 
experiences gained from previous meetings. The use of storytelling will be used to simulate discussion 
[22]. 
 
Figure 1. Overview of the baby health meetings  
 
 
 

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Set-up 
The BHM will be conducted in the HCs chosen to be in the intervention group. Both prior to the meeting 
and after it refreshments will be served.  The group will decide whether they want to sit on chairs or the 
floor. At the start of the first meeting ground rules will be discussed and agreed upon; these will be written 
in Khmer and displayed at each subsequent meeting. Flip charts, post it notes and pens will available during 
each session to help clarify points and to reach consensus about topics. These charts will be photographed 
at the end of each meeting. All participants will receive their travel costs, calculated by distance travelled 
and at a fixed rate and paid at the end of the meeting. 
Conducting the Meetings 
The meetings will be conducted in Khmer by one of the SBLT. A focus group discussion like method will be 
used, with the SBLT member encouraging discussion and interaction in the group. A meeting topic guide 
will be used for each meeting (Appendix 1. Baby Health Meeting topic guide 
Recording the Meetings 
An observer will be present to take notes on nonverbal communication and interactions using a meeting 
observation form (Appendix 1. Baby Health Meeting topic guide 

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Appendix 2). Each participant will be given an ID number and these will be used so that the note taker can 
draw a map of where people were sitting and attribute contributions to specific people. 

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Contact Summary Forms 
At the end of each meeting the SBLT will meet and complete a contact summary form, documenting the 
meeting process (Appendix ).  
Perinatal Mortality 
The expected outcome of the SBLP is a reduction in perinatal mortality (PMR). In order to assess the 
effectiveness of the SBLP an accurate measure of PMR is needed. Although births and deaths are required 
to be registered in Cambodia, often the births and deaths of young infants, particularly those born at 
home, are not registered. To accurately determine the perinatal mortality rate (PMR) in PVH province, 
government village health support groups (VHSG) will be asked to record details of all births and neonatal 
deaths in their villages. The data collected will include: 
1. Village name 
2. Estimated Date of Delivery  
3. Date of delivery 
4. Gender 
5. Prematurity 
6. Place of delivery 
7. Birth weight  
8. Alive at 28 days 
The data will be brought to monthly VHSG meeting and entered in to a database by a member of the SBLT. 
Each VHSG will receive a $2 phone credit card for each completed birth data collected. If a neonate dies, 
a verbal autopsy will be performed by one of the Saving Babies Lives team using the WHO Verbal autopsy 
tool [23].  
Economic Evaluation 
A detailed cost analysis will be carried out to estimate the added resources that are required for the SBLP 
as compared with standard care. These costs will be combined with estimates for the incremental cost of 
caring for children at AHC, and HCs if attendance is found to increase, and by modelling the subsequent 
survival benefits in terms of incremental disability adjusted life years averted. This will indicate whether 
the SBLP is as cost-effective as compared to the existing standard of care (control arm).  
At the time of the newborn health questionnaire, the mother will be asked about any health seeking costs 
the family incurred for their infant in the first four weeks of life. 
3.3. Study Site 
Preah Vihear is one of the most remote and isolated provinces in Cambodia. The province has a population 
of around 172,000 people spread out through 293 villages in eight districts. The mainly rural population 
survive on sustenance farming. Within the province there are 28 government HC, 17 HP, and one referral 
hospitals. Each HC and HP serves a number of villages and is the first point of access for health care. There 
are approximately 5,300 recorded deliveries in the province per year (data obtained from PVH provincial 
health offices).  
4. OBJECTIVES AND OUTCOME MEASURES 
 

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Objectives 
Outcome Measures  
Time point(s) of 
evaluation of this 
outcome measure 
(if applicable) 
Primary Objective 
The design, implementation and 
assessment of a comprehensive 
community neonatal heath package 
utilising medical and social 
interventions 
A comprehensive community neonatal 
heath package utilising medical and social 
interventions 
Study end 
Secondary Objective 
Reduction of perinatal mortality in 
PVH province, Cambodia 
A one third reduction in perinatal 
mortality in PVH province, Cambodia 
Study end 
Tertiary Objectives: 
To describe the characteristics of 
neonates born in PVH province, 
Cambodia over a five-year time 
period 
A document that describes characteristics 
of neonates, born in PVH province, 
Cambodia over a five-year time period 
Study end 
To develop a tool to undertake a 
full review of neonatal services and 
capabilities in PVH province, 
Cambodia 
a. Assess the level of knowledge 
possessed by health care 
workers with respect to 
fundamental areas of care 
surrounding delivery and the 
neonatal period 
b. Evaluate current practice 
regarding delivery and neonatal 
care 
c. Undertake a review of health 
centre facilities and resources 
d. Record the staff composition 
and working patterns 
e. Detect commonalties as well as 
differences between facilities 
f. Assess the local community 
service provision, including the 
activity of the VHSGs as well as 
any other community health 
projects and initiatives 
A user-friendly tool to assess neonatal 
healthcare services 
A report detailing neonatal services and 
capabilities in PVH province, Cambodia 
Study end 

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g. Identify factors that may be 
functioning as barriers and 
facilitators to improvements in 
the delivery of care 
Design a fully comprehensive 
neonatal healthcare and 
implementation package adapted 
to local need 
a. Provide health workers with 
essential knowledge with 
respect the neonatal period. 
b. Design a programme to teach 
that is acceptable and feasible 
for government health workers 
c. Empower healthcare providers 
to make positive changes in 
order to overcome any barrier 
to improvement. 
d. Equip each facility with the 
resources required to safely 
resuscitate a neonate and 
provide ongoing neonatal care 
as required.  
A locally appropriate neonatal healthcare 
training and implementation package 
Study end 
Establish VHSG groups to address 
areas of concern for the local 
community with respect to 
childbirth and the neonatal period 
a. To identify issues 
communities, have in 
relation to neonatal health, 
and which interventions 
are seen as priorities to 
improve neonatal health 
care 
Frequency and attendance rate of 
participants at the programmes meetings 
Study end 
With the Kingdom of Cambodia, 
Ministry of Health and the 
Provincial Health Director of PVH 
province develop a programme 
blueprint and implementation 
strategy for introduction of the 
developed programme into other 
locations within Cambodia 
A programme and implementation plan 
for the reduction of neonatal mortality 
that can be used throughout Cambodia 
Study end 

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To calculate the cost-effectiveness 
of a neonatal community health 
programme and the resulting 
changes in care, as compared to 
the existing care given in the 
region. 
 
 
5. STUDY DESIGN 
A cluster randomised study design will be used, with a cluster being defined as a HC administrative group, 
as defined by the PVH Provincial Health Department. This includes all HC, HP, villages, and villagers in that 
group.  
Pilot: 
 
 
to begin in July 2018, consisting of 4 clusters. 
Intervention arm: 
to begin October 2019, consisting of 10 clusters. 
Control arm: 
 
all remaining clusters.  
Completion: 
 
December 2022. 
The SBLP will be introduced into the provincial referral hospital during 2018. 
The SBLP will be introduced into the new referral hospital during 2022. 
The choice of which health centres will be included at each time point will be made using purposive 
sampling to ensure a mix of health centre characteristics. Characteristics that will be taken into account 
are the distance from the health centre to the referral hospital and number of villages the HC serves. 
6. PARTICIPANT IDENTIFICATION AND RECRUITMENT 
6.1. Saving Babies Lives Training Programme 
6.2. Study Participants 
The Saving Babies Lives Programme will be aimed at government health care staff working in the 
community (VHSG), at HC (nurses and midwives) and at the referral hospital (doctors and nurses) 
6.3. Inclusion Criteria 
 
Staff members chosen by the Provincial Health Director to attend the programme 
6.4. Exclusion Criteria 
 
Not applicable 
6.5. VHSG Baby Health Meetings 
6.6. Study Participants 
 
Two VHSG from villages served by each HC cluster 
 
Adults (aged 18 years or older) 

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6.7. Inclusion Criteria 
 
Work as a VHSG 
 
Live in a village served by a chosen HC 
 
Are able to commit to attend meetings regularly  
 
Give consent to participate in the meetings 
6.8. Exclusion Criteria 
 
Refusal to participate 
 
Be from a village where two members have already been chosen 
7. STUDY PROCEDURES 
7.1. Saving Babies Lives Programme 
7.2. Recruitment 
Not applicable 
7.3. Screening and Eligibility Assessment 
Not applicable 
7.4. Informed Consent 
Not applicable 
7.5. Discontinuation/Withdrawal of Participants from Study 
 
 
Each participant has the right to withdraw from the SBLP at any time.   
 
The reason for withdrawal will be recorded in the teaching attendance log book. 
7.6. VHSG Baby Health Meetings  
7.7. Recruitment 
The Saving Babies Lives Team (SBLT) will visit all health centres and give a presentation about the project.  
All VHSGs will be invited to take part in the meetings 
Each VHSG will be approached (face-face) and asked whether they give consent to be in the BHM. 
Demographic data will be collected from all VHSG. A short questionnaire administered to assess knowledge 
on neonatal health, attitudes towards neonatal health and their practice as VHSG. This questionnaire will 
be repeated on an annual basis to observe changes in responses over time. 
If a participant leaves the group, their replacement VHSG will be approached and asked to join the group.  
7.8. Informed Consent 
Formal written consent for the VHSG to participate in the BHM will not be taken. This decision has been 
made for the following reasons: 

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1. Consent will be inferred by the fact that the VHSG is attending the meeting. The individuals will 
only take an active role in the discussion if they wish to 
2. The Provincial Health Director of PVH regards attendance at the BHMs as being part of the normal 
role of the VHSG and has requested that no special procedures be undertaken 
7.9. Discontinuation/Withdrawal of Participants from Study 
 
Each participant has the right to withdraw at any time. In addition, the Investigator may discontinue a 
participant from the study at any time if the Investigator considers it necessary for any reason including: 
 
Non-attendance at three or more meetings within one year 
 
Withdrawal of Consent 
The reason for withdrawal will be recorded  
8. STATISTICS AND ANALYSIS 
8.1. Description of Statistical Methods 
VHSG Baby Health Meetings 
Summary forms from the BHM will be translated into English.  Ten percent of data will be double translated 
and transcribed and the two versions compared for errors. The data will be exported into a qualitative 
software package (N-Vivo 10 (QSR International, Cambridge, MA). After data entry an analytical framework 
will be developed to identify common and emerging themes, which will then be coded. Once the codes 
have been developed they will be applied to the whole data set for interpretation of the data.  Quantitative 
data will be used to contextualise the qualitative data [14-16]. Ethnographic and content thematic analysis 
will be performed on the data generated by the BHM. This will focus on process evaluation and outcome 
evaluation. The Medical Research Council guidelines for evaluating complex interventions will be used as 
a guide [24]. 
Primary Outcome: 
 
Factors associated with the success or failure of the engagement process 
o Factors to explore: 
- 
Involvement of group members in the meeting 
- 
Cohesiveness of the group 
- 
Taking message back to the community 
- 
Acceptability of the process 
- 
Appropriateness of group members 
- 
Factors influencing the ability / inability of the VHSG to implement suggested 
interventions 
Secondary Outcomes: 
 
Changes in the VSHG’s knowledge, attitudes and practices in neonatal health over time 
 
VHSG’s perceptions of neonatal health issues in rural Cambodia 

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 
Interventions suggested to improve neonatal care and reasons behind them 
 
Acceptability of the groups to the community / health providers / community leaders 
 
Acceptability to the group 
 
VHSG’s perception of the effectiveness of interventions  
 
Involvement of community members with the program  
 
Perinatal Mortality 
The analysis will be performed by intention to treat; mothers and their infants who began the study as 
residents of one cluster will remain in that group even if they move to another cluster.  
Primary Outcome:  
1. Perinatal mortality rate will be described by hazard rate and 95% confidence interval (CI) separated 
by groups. Survival between groups will also be described using Kaplan-Meier plot. Log-rank test 
will be used for univariate comparison of survival. We will also describe median time to perinatal 
death with 95% CI in each group from Kaplan-Meier plot. 
Secondary Outcomes: 
1. Description of the cohort 
a. Prematurity 
b. Birth weight 
c. Sex 
2. Facility based deliveries 
 
Facility based deliveries prematurity, sex, will be described using percentage and compared 
between groups using Chi-square test or Fisher’s exact test as appropriate. Number of ANC visits will be 
described using median with inter-quartile range (IQR) and compared between groups using Mann-
Whitney U test. Birth weight will be described using mean with standard deviation and compared between 
groups using Student’s t test or using median with inter-quartile range and compared between groups 
using Mann-Whitney U test if data have non-normal distribution.  
Statistical analysis will be performed using STATA software package. Statistical significance will be 
considered if p-value < 0.05 
 
Sample size Calculation 
With perinatal mortality rate and a simple parallel cluster randomised trial design, the number of clusters 
are fixed to the intervention and control arm clusters and the time-frame is fixed to five years. The 
change in study design has been necessitated by logistical reasons and the post-study power calculations 
are not relevant. We will report limitations to the power in write-up.  
The statistical analysis will remain broadly the same, with the main difference being that we will no 
longer adjust for the confounding effects of time. The primary analysis will exclude pilot cluster results, 
and will only be conducted on the intervention and control arm clusters. 
Please see the study Statistical Analysis Plan for full details.  

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Economic Evaluation 
A detailed cost analysis will be carried out to estimate the added resources that are required for the SBLP 
as compared with standard care. These costs will be combined with estimates for the incremental cost of 
caring for neonates at the referral hospital if attendance is found to increase, and by modelling the 
subsequent survival benefits in terms of incremental disability adjusted life years averted. This will indicate 
whether SBLP are cost-effective as compared to the normal standard of care (control arm).  
9. DATA MANAGEMENT 
9.1. Access to Data 
Direct access will be granted to authorised representatives from the University of Oxford and any host 
institution for monitoring and/or audit of the study to ensure compliance with regulations. 
9.2. Data sharing 
Data collected for this study will be under the custodianship of AHC, will be de-identified and may be 
shared with other groups of researchers in accordance with the current MORU Data Sharing Policy. 
(http://www.tropmedres.ac/data-sharing-policy) All applications will be carefully reviewed by the MORU 
Data Access Committee before granting any approvals to access data. All researchers accessing the data 
need to adhere to a set of terms and conditions that aim to protect the interests of research participants 
and other relevant stakeholders. 
9.3. Data Handling and Record Keeping 
During Field Work 
Notes will be kept with the SBLT at all times or in a locked vehicle to ensure confidentiality. Non SBLT 
members will not be permitted to look at the notes. Content of the discussions will not be revealed to 
anyone else. 
After the Field Work 
All notes will be taken to the SBL office at the end of the day. The paper notes will be stored in a locked 
filing cabinet prior to data entry. Following data entry, the files will be kept on a on a secure, password 
encrypted server. The server will be backed up to tape every day and the tapes kept in a secure off-site 
location. 
10. QUALITY CONTROL AND QUALITY ASSURANCE PROCEDURES 
Prior to commencement of programme the team will be trained in teaching and facilitation methods and 
techniques. In addition, they will be trained in the programme specific data collection and in GCP. The 
study will be conducted in accordance with relevant regulations and standard operating procedures. 
11. ETHICAL AND REGULATORY CONSIDERATIONS 

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11.1. 
Declaration of Helsinki 
The Investigator will ensure that this study is conducted in accordance with the principles of the 
Declaration of Helsinki.  
11.2. 
Guidelines for Good Clinical Practice 
The Investigator will ensure that this study is conducted in accordance with relevant regulations and with 
Good Clinical Practice. 
11.3. 
Approvals 
The protocol and any proposed advertising material will be submitted to OxTREC and the Cambodian 
National Ethics Committee for written approval. 
Permission to introduce this programme will be sought from the Government of the Kingdom of Cambodia. 
The Investigator will submit and, where necessary, obtain approval from the above parties for all 
amendments to the original approved documents. 
11.4. 
Participant Confidentiality 
The study staff will ensure that the participants’ anonymity is maintained.  The participants will be 
identified only by a participant ID number on all study documents and any electronic database, with the 
exception of the CRF, where participant initials may be added.  All documents will be stored securely and 
only accessible by study staff and authorised personnel. The study will comply with the Data Protection 
Act, which requires data to be anonymised as soon as it is practical to do so. 
11.5. 
Expenses and Benefits 
Reasonable travel expenses for any visits additional to work will be reimbursed. 
11.6. 
Reporting 
The CI shall submit an Annual Progress Report to OxTREC on the anniversary of the date of approval of the 
study. In addition, the CI shall submit an End of Study Report to OxTREC within 12 months of completion 
of the study. 
12. FINANCE AND INSURANCE 
12.1. 
Funding 
Funding is actively being sought 
12.2. 
Insurance 
The University has a specialist insurance policy in place which would operate in the event of any participant 
suffering harm as a result of their involvement in the research (Newline Underwriting Management Ltd, at 
Lloyd’s of London).   
13. PUBLICATION POLICY 

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The results of the evaluation of the programme will be shared with the Kingdom of Cambodian MoH, 
presented at relevant national and international meetings and submitted for publication in an 
international peer-reviewed journal.  
 
 

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14. REFERENCES 
1. 
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participation: lessons for maternal, newborn, and child health. Lancet. 2008;372(9642):962-71. Epub 
2008/09/16. doi: 10.1016/S0140-6736(08)61406-3. PubMed PMID: 18790319. 
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Lawn JE, Cousens S, Zupan J. 4 million neonatal deaths: when? Where? Why? Lancet. 
2005;365(9462):891-900. Epub 2005/03/09. doi: S0140-6736(05)71048-5 [pii] 
10.   1016/S0140-6736(05)71048-5. PubMed PMID: 15752534. 
9. 
Turner C, Carrara V, Aye Mya Thein N, Chit Mo Mo Win N, Turner P, Bancone G, et al. Neonatal 
Intensive Care in a Karen Refugee Camp: A 4 Year Descriptive Study. PloS one. 2013;8(8):e72721. doi: 
10.1371/journal.pone.0072721. 
10. Engmann C, Adongo P, Aborigo RA, Gupta M, Logonia G, Affah G, et al. Infant illness spanning the 
antenatal to early neonatal continuum in rural northern Ghana: local perceptions, beliefs and 
practices. Journal of perinatology : official journal of the California Perinatal Association. 
2013;33(6):476-81. Epub 2013/01/26. doi: 10.1038/jp.2012.151. PubMed PMID: 23348868. 
11. Barennes H, Simmala C, Odermatt P, Thaybouavone T, Vallee J, Martinez-Aussel B, et al. Postpartum 
traditions and nutrition practices among urban Lao women and their infants in Vientiane, Lao PDR. 
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10.1038/sj.ejcn.1602928. PubMed PMID: 18000519; PubMed Central PMCID: PMC3435433. 
12. Herlihy JM, Shaikh A, Mazimba A, Gagne N, Grogan C, Mpamba C, et al. Local perceptions, cultural 
beliefs and practices that shape umbilical cord care: a qualitative study in southern province, zambia. 
PloS one. 2013;8(11):e79191. Epub 2013/11/19. doi: 10.1371/journal.pone.0079191. PubMed PMID: 
24244447; PubMed Central PMCID: PMC3820671. 
13. Marston C, Renedo A, McGowan CR, Portela A. Effects of community participation on improving 
uptake of skilled care for maternal and newborn health: a systematic review. PloS one. 
2013;8(2):e55012. Epub 2013/02/08. doi: 10.1371/journal.pone.0055012. PubMed PMID: 23390509; 
PubMed Central PMCID: PMC3563661. 
14. Prost A, Colbourn T, Seward N, Azad K, Coomarasamy A, Copas A, et al. Women's groups practising 
participatory learning and action to improve maternal and newborn health in low-resource settings: 
a systematic review and meta-analysis. Lancet. 2013;381(9879):1736-46. Epub 2013/05/21. doi: 
10.1016/S0140-6736(13)60685-6. PubMed PMID: 23683640. 
15. Rosato M, Mwansambo CW, Kazembe PN, Phiri T, Soko QS, Lewycka S, et al. Women's groups' 
perceptions of maternal health issues in rural Malawi. Lancet. 2006;368(9542):1180-8. Epub 
2006/10/03. doi: 10.1016/S0140-6736(06)69475-0. PubMed PMID: 17011945. 
16. Lewycka S, Mwansambo C, Rosato M, Kazembe P, Phiri T, Mganga A, et al. Effect of women's groups 
and volunteer peer counselling on rates of mortality, morbidity, and health behaviours in mothers 
and children in rural Malawi (MaiMwana): a factorial, cluster-randomised controlled trial. Lancet. 
2013;381(9879):1721-35. Epub 2013/05/21. doi: 10.1016/S0140-6736(12)61959-X. PubMed PMID: 
23683639. 
17. Azad K, Barnett S, Banerjee B, Shaha S, Khan K, Rego AR, et al. Effect of scaling up women's groups on 
birth outcomes in three rural districts in Bangladesh: a cluster-randomised controlled trial. Lancet. 

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2010;375(9721):1193-202. Epub 2010/03/09. doi: 10.1016/S0140-6736(10)60142-0. PubMed PMID: 
20207412. 
18. Manandhar DS, Osrin D, Shrestha BP, Mesko N, Morrison J, Tumbahangphe KM, et al. Effect of a 
participatory intervention with women's groups on birth outcomes in Nepal: cluster-randomised 
controlled 
trial. 
Lancet. 
2004;364(9438):970-9. 
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2004/09/15. 
doi: 
10.1016/S0140-
6736(04)17021-9. PubMed PMID: 15364188. 
19. WHO. Every Newborn: an action plan to end preventable deaths.2014. 
20. Wall SN, Lee AC, Niermeyer S, English M, Keenan WJ, Carlo W, et al. Neonatal resuscitation in low-
resource settings: what, who, and how to overcome challenges to scale up? International journal of 
gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and 
Obstetrics. 2009;107 Suppl 1:S47-62, S3-4. Epub 2009/10/10. doi: 10.1016/j.ijgo.2009.07.013. 
PubMed PMID: 19815203; PubMed Central PMCID: PMC2875104. 
21. Cambodia Ko. Cambodia Demographic and Health Survey 2010. Preliminary Report March 2011. 
2010. 
22. Rath S, Nair N, Tripathy PK, Barnett S, Mahapatra R, Gope R, et al. Explaining the impact of a women's 
group led community mobilisation intervention on maternal and newborn health outcomes: the Ekjut 
trial process evaluation. BMC international health and human rights. 2010;10:25. Epub 2010/10/26. 
doi: 10.1186/1472-698X-10-25. PubMed PMID: 20969787; PubMed Central PMCID: PMC2987759. 
23. WHO. Verbal Autopsy Standards: 2012 WHO Verbal Autopsy Instrument: WHO Press; 2012. 
24. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex 
interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655. Epub 2008/10/01. 
doi: 10.1136/bmj.a1655. PubMed PMID: 18824488; PubMed Central PMCID: PMC2769032. 
25. You D HL, Ejdemyr S, Beise J, Idele P, Mathers C. Levels and Trends in Child Mortality. Report 2015. 
Estimates Developed by the UN inter-agency Group for Child Mortality Estimation. United Nations 
Child. 2015. 
26. MOH. Cambodia Demographic and Health Survey 20122010. 
27. Fottrell E, Azad K, Kuddus A, Younes L, Shaha S, Nahar T, et al. The Effect of Increased Coverage of 
Participatory Women's Groups on Neonatal Mortality in Bangladesh: A Cluster Randomized Trial. 
JAMA pediatrics. 2013;167(9):816-25. Epub 2013/05/22. doi: 10.1001/jamapediatrics.2013.2534. 
PubMed PMID: 23689475. 
28. Tripathy P, Nair N, Barnett S, Mahapatra R, Borghi J, Rath S, et al. Effect of a participatory intervention 
with women's groups on birth outcomes and maternal depression in Jharkhand and Orissa, India: a 
cluster-randomised controlled trial. Lancet. 2010;375(9721):1182-92. Epub 2010/03/09. doi: 
10.1016/S0140-6736(09)62042-0. PubMed PMID: 20207411. 
29. Pagel C, Prost A, Lewycka S, Das S, Colbourn T, Mahapatra R, et al. Intracluster correlation coefficients 
and coefficients of variation for perinatal outcomes from five cluster-randomised controlled trials in 
low and middle-income countries: results and methodological implications. Trials. 2011;12:151. Epub 
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PMC3136407. 
   
 
 

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15. Appendices 
Appendix 1. Baby Health Meeting topic guide 
 

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Appendix 2. Meeting observation form 
 

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Appendix 3. VHSG meeting contact form 
 

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