Newborn Infection Control and Care Initiative for Health Facilities to Accelerate Reduction of Newborn Mortality
Newborn Infection Control and Care Initiative for Health Facilities to Accelerate Reduction of Newborn Mortality
Newborn mortality continues to be unacceptably high in Cambodia, despite reductions in
 maternal and under five year old mortality. Evidence exists that a large proportion of
 newborn mortality globally and in Cambodia is attributable to infections and sepsis. The
 study proposes a package intervention to address infection control in the perinatal period in
 facilities and to improve the timeliness of referral of newborns with suspected infections to
 appropriate health facilities for treatment through upgrading of hygiene practices in
 facilities and linking of community based volunteers with health facilities and families in
 the community setting.

 By delivering a coordinated intervention that combines improved education for health center
 midwives, village health care workers, and mothers of newborns, along with improved care
 coordination with increase in number of interactions (points of contact) between mothers and
 health care personnel, the investigators will see improved knowledge of newborn danger signs
 among mothers and health care workers, more rapid case detection of significant newborn
 illnesses, and more rapid and appropriate referral of ill newborns.

 The investigators also hypothesize that the common causes of newborn sepsis in Cambodia are
 different from those reported in Western cultures, and that Staphylococcus aureus will be a
 common pathogen as described in neighboring Laos. The investigators will evaluate the causes
 of newborn sepsis in the subset of infants referred to Takeo Provincial Hospital.
The study will incorporate mixed methods: formative (qualitative) research, and a stepped
 wedge cluster randomized intervention trial and process evaluation. It is anticipated that
 the results of this study will provide data for policy level actions on newborn survival in
 Cambodia and in other settings with similar health outcomes. The study may contribute to the
 potential scale up of a linked model of community-facility care for newborns.

 Globally, infection causes approximately 35% of all newborn mortality [1]. Verbal autopsy
 data collected in Svay Rieng province in 2009 show that bacterial sepsis is the likely cause
 in 40% of newborn deaths, by far the largest category (exceeding the next highest cause by
 17%) [2].

 The NICCI intervention addresses a number of barriers identified by the Royal Government of
 Cambodia and USAID to improving neonatal survival, including the capacity and performance of
 health providers to deliver newborn care through strengthened training; upgrading hygiene
 through enhanced infection control in facilities; and increasing community engagement in the
 demand for and delivery of health services for newborns through improving referral processes
 and addressing barriers to timely care seeking. The proposed study will address the crucial
 gap in post-natal care by linking the community (via Village Health Support Groups) with
 Health Center staff to follow mothers and newborns during the first week of life

 Quality Assurance: Investigators will include provision for the management of all data
 collection and will include appropriate procedures in a Standard Operating Practices
 document. Training of data collectors at the start of the study will ensure quality and
 consistency and supervisory monitoring of data collection will occur monthly.

 Data Checks and Data Source Verification: Data will be collected, checked, and entered into a
 data management system at the National Institute of Public Health. All participants will be
 identified by a unique identifier which will be the link for all databases. All study data
 will be collected by project staff so outcomes do not depend on subject compliance other than
 refusal to answer project surveys (although study participants always have a right to decline
 to answer a survey based on informed consent principles). Data collected in the community
 will be transferred to central databases at NIPH and entered into a database using REDcap or
 a comparable program that is compatible with data management capacity at NIPH. The
 investigators will use special screens with filters for invalid entries and identification of
 missing values for data entry verification. Analysis will be conducted in SPSS and/or SAS.

 Sample Size: Using all cause newborn mortality as the primary outcome and stepped wedge
 design sample size calculation (power analysis) for cluster randomized trials, the
 investigators required a total sample size of 1,938 subjects based on 80% power, 5%
 significance level, and 10% rate of loss-to-follow up to detect a 20% reduction with a
 baseline neonatal mortality of 40 deaths/1,000 live births in target provinces and an
 intra-class correlation coefficient of 0.0007256.

 Withdrawal from the Study: Study subjects may withdraw voluntarily from participation at any
 time. Participants may also voluntarily withdraw from receiving the study intervention at any
 time. The study team will attempt to follow those who withdraw from the study in order to
 collect safety data if applicable.

 Termination of Study: Although very unlikely, discontinuation would occur if a statistically
 significant increase or decrease in neonatal deaths was detected in the intervention area and
 reasons for that correlated in any way to the content of the intervention.

 Formative Study:

 The investigators will conduct qualitative data collection from FGD with staff from 15 health
 centers, one-on-one interview with 20 VHSG and with 30 mothers of newborn. The study will
 allow us to get an overall knowledge on the knowledge and practices on newborn by HC and
 community before the implementation phase.

 The baseline data will be collected from the comparison cluster during the course of
 intervention phase, environmental assessment checklist used in the health facilities which
 the investigators will use before the start of the intervention and during the interventions,
 and the planned formative research.

 Intervention Study:

 Determine the 1st HC for conducting the intervention. The investigators will randomly select
 one health center (HC) from among the 16 HCs. For the second and the subsequent HCs, the
 investigators will select the HC which is close to the first HC, and the investigators will
 continue this process until all the 16 HC are selected.

 Training HC Staff: during the training for the first HC (which will be happening in the first
 month of the intervention phase), MCH (Maternal and Child Health) Focal Person and SC will
 conduct the training and HC Coordinators/other project staff will observe the training.
 Subsequent training for the HC staff will be conducted by HC Coordinators with the
 supervision support from Provincial Health Department (PHD) MCH Focal Person and SC. NICCI
 will conduct training for one HC each month. Before each training starts, the trainers will
 introduce a HC Data Form (only the relevant parts) to collect baseline data from the
 trainees. This training will go over a period of 16 months for the 16 health centers.

 Training VHSG: during the first month of the intervention phase, the investigators will also
 organize training for VHSG under the HC's coverage (one HC at a time). This training will go
 over a period of 16 months. Before each training starts, the trainers will introduce VHSG
 Data Form (only relevant parts) to collect baseline data from the trainees.

 Blood Samples from Sick Newborn: The investigators anticipate that pathogenic bacteria will
 be isolated in about 10% of the 200-300 blood samples to be tested over the 2 year period of
 the intervention-control study.

 HC Coordinators Conduct Supportive Supervision to HC Staff in Intervention Clusters: the two
 HC Coordinators will jointly conduct monthly supportive supervision to the HC under the
 Invention Cluster. During the supervision, the HC Coordinators will perform the following:

 Check whether NICCI's training/education materials for HC are available and used by HC staff;
 discuss with HC staff whether the staff recall 6 newborn danger signs and hygiene messages
 (hygiene for mothers/newborn/home and hygiene for HC staff themselves including knowledge on
 infection control); re-enforce HC staff (observe if applicable) to provide education to
 mothers on newborn care, newborn danger signs, and hygiene at home; re-enforce the practice
 of infection control according to NICCI training materials, and check whether HC staff have
 the skill and the materials/supplies to implement the infection control activities as written
 in the training materials; review birth register and ANC registers to assist HC staff in care
 coordination and assist VHSG Coordinators in pregnant women enrollment, e.g. HC communicate
 more effectively with VHSG; check whether HC staff, who provide ANC services, ask the
 pregnant women about meeting with VHSG in their villages, if the pregnant women have not met
 VHSG, HC needs to provide information about the pregnant women to relevant VHSG (call VHSG
 telephone), HC Coordinators can assist in this activity by comparing the name of pregnant
 women in the HC ANC register with the enrollment list; check whether the HC staff have done
 their work on care coordination with VHSG (e.g. call VHSG after the mother/newborn leave the
 HC) and inform VHSG on pregnant women enrollment as they have been trained; re-enforce this
 practice or confirm the HC staff if the HC staff have done properly; check whether the HC has
 an update enrollment list (so that HC staff know whether a woman come for delivery is the
 study participant). HC Coordinators need to work with VHSG Coordinators to ensure that HC
 staff have an up to date list (e.g. up to a month preceding the month in which HC Coordinator
 conduct the supervision).

 The two HC Coordinators must have a supportive supervision book to record what activities the
 HC Coordinators have done during each supervision visit, with a clear supervision date and
 name of the HC. The record for each supervision visit should be ended by a summary of the
 finding and follow up actions.

 HC Coordinators Conduct Weekly Visit to Each HC Under Comparison Clusters: the purpose of the
 visit is to collect information about the enrolled participants who have birth delivery in
 the HC so that the project has the information to interview the mothers/newborn in their
 villages on the 14th and 28th day after the delivery. In the visit, HC Coordinators collect
 the information and share the information with Data Manager. The Data Manager registers the
 information in the database and provide information to VHSG Coordinators for the VHSG
 Coordinators to meet each mother/newborn on the 14th day and on the 28th day. The information
 include: participant name and ID, and date of delivery. During the visit, HC Coordinators
 will also provide up to date enrollment list to the HC. It is also an option if the HC
 Coordinators think that they can secure this activity without visiting the HC and with only
 communicate with the HC through mobile phone

 VHSG Coordinators Conduct Supportive Supervision to VHSG in Intervention Cluster: each VHSG
 Coordinator will be assigned to be responsible for approx. 54 villages, and needs to conduct
 supervision to each village every two months; the supervision will be conducted only for
 villages where VHSG have already been trained by NICCI. With the guidance from SC, VHSG
 Coordinators will develop a written schedule for VHSG supervision (two monthly schedule,
 which is equal to one round of supervision). During the supervision to each eligible village
 (meeting VHSG), the VHSG Coordinators will perform the following:

 Check VHSG Pregnant Women Register to see whether VHSG has conducted proper registration:
 complete the register correctly, seem to register all the pregnant women (according to the
 estimated number of pregnant women in each village) Check VHSG whether they have communicated
 with their relevant HC on: mother coming home and other care coordination, and whether HC
 informed them about pregnant women in their villages and who have not been registered or
 contacted by the VHSG.

 Discuss with VHSG about their knowledge, re-enforce their knowledge on: 6 newborn danger
 signs, newborn care as in the training/education materials, home hygiene by the family,
 message on care seeking; and check whether the VHSG have and use the NICCI's
 training/education/thermometer materials and re-enforce the use of the education materials
 when necessary.

 Discuss whether VHSG conduct the three visits to mother/newborn: 24hours, 3rd, and 7th day,
 and discuss with VHSG whether they understand and use the VHSG Home Visit's materials.

 Enroll/interview new pregnant women (using Consent Form and the Enrollment and Baseline
 Form), provide the completed forms to the Data Manager.

 Each VHSG Coordinator must have a supervision record book, recording activities they have
 done during each supervision visit to each village (with name of VHSG), with a summary of the
 findings and clear follow up actions. SC will design this supervision Record Book for the
 VHSG Coordinators.

 VHSG Coordinators Enroll Pregnant Women in Comparison Clusters: each VHSG Coordinator will
 travel to their designated villages under the comparison cluster every two months. During
 each visit, the VHSG Coordinators will perform the followings:

 Discuss with VHSG to assist them in completing the pregnant women registration Meet with
 pregnant women (with the support from VHSG) who meet the criteria of enrollment (e.g. at
 their last semester of pregnancy) to enroll the pregnant women using Consent Form, and the
 Enrollment and Baseline Form.

 HC Coordinators Conduct Data Collection from HC: the two HC Coordinators will jointly conduct
 the data collection from each HC every six months, using HC Data Collection Form. After
 completing, the HC Coordinators send the Form to Data Manager for his/her verification and
 data entry. SC and Data Manager will work closely with and assist HC Coordinators in the
 development of data collection plan for each data collection round (one round lasts for six
 month). The Data Manager will help SC to closely monitor HC Coordinators in adhering to the
 data collection plan and provide prompt feedback to SC and HC Coordinators.

 VHSG Coordinators Conduct Data Collection from VHSG: each VHSG Coordinator will conduct
 interview with VHSG who work in their designated villages (approx. 50 village per VHSG
 Coordinator) every six month, using VHSG Data Form. After completing the Form, VHSG
 Coordinators send the completed Form to Data Manager for his/her verification and data entry.
 SC and Data Manager will work closely with and assist VHSG Coordinators in the development of
 data collection plan for each data collection round (one round lasts for six month), the Data
 Manager will help SC to closely monitor VHSG Coordinators in adhering to the data collection
 plan and provide prompt feedback to SC and VHSG Coordinators.

 VHSG Coordinators Conduct Data Collection from Mothers/Caretakers: each VHSG Coordinator
 ensures that all registered mother/newborn (in his or her designated villages) are
 interviewed on the 14th and the 28th day after delivery. To know whether VHSG Coordinator has
 a mother/newborn to interview for a month, the VHSG Coordinator needs to work closely with
 the data manager who will generate the list of mother/newborn to visit on the 14th and on the
 28th day.
Inclusion Criteria:

 -  Health Centers: historically, a health center which providing services for more than
 20 births per month

 -  Individuals: women in the last trimester of pregnancy with any ethnicity, age is equal
 or older than 18 years, and pregnancy results in a live birth.

 Exclusion Criteria:

 -  Birth of baby with known congenital malformation

 -  Inability to obtain informed consent or adhere to protocol