Newborn Infection Control and Care Initiative for Health Facilities to Accelerate Reduction of Newborn Mortality (NICCI): Results of a Stepped Wedge Cluster-Randomized Controlled Trial

Abstract

Objectives: The intervention study objectives were to improve infection control behavior by staff in health centers; improve referral of sick newborns, increase recognition of danger signs, and prompt care seeking at appropriate health facility; and appropriate referral for sick newborns by mothers and families of newborn infants Methods: The stepped wedge cluster randomized controlled trial in 16 Health Centers (HC) took place from February 2015 and November 2016. Each cluster was one HC its catchment area. Eligible HCs were those with greater than 20 birth deliveries per month. Eligible participants in each cluster included women in their last trimester of pregnancy who were healthy and able to participate in the intervention activities, such as home visits and data collection, could adhere to the study protocol, and were greater than 18 years of age. Participants enrolled in the study who met all inclusion criteria were blinded to their group assignment and interviewed by the study during the last trimester of her pregnancy (enrollment), the 14th day after delivery, and on the 28th day after delivery. The study team was not blinded to group assignment. At the HCs, the intervention included training on hand washing, infection prevention control, newborn danger signs, breastfeeding, and newborn care. Health workers were trained to conduct home visits within 24 hours of birth and on days 3 and 7 after delivery, including assessment of newborns for danger signs, counselling mothers at home visits, and use of equipment (e.g. thermometers). At home visits, mothers and caregivers received counseling on hygiene and handwashing practices, breastfeeding, newborn danger signs, and prompt, appropriate referral to facilities. Results: HC staff in the intervention group had 14.6 times (7.73-31.47; p<0.0001) the likelihood of hand washing at the recommended key moments when compared to the control group, and 98% of HC staff in the intervention group knew six danger signs compared to 15% in the control group (p<0.0001), while 95% recalled at least three hygiene messages compared to 54% in the control group (p<0.0001). 60.58% of VHSG volunteers in the intervention group knew at least six danger signs compared to 2.11% of VHSG in the control group (p<0.0001). Of 2,494 mother participants in the trial, at 14th days after delivery, women in the intervention group were more than twice as likely to know at least 3 danger signs compared to women in the control group (OR=2.35, p=0.0104), with no effect on care seeking behavior. However, 35.01% of mothers in the intervention group received messages on care seeking from VHSG volunteers compared to 5.35% in the control group (p<0.0001). Conclusions: Well-designed training followed by regular supervision improved the knowledge and self-reported behavior of HC staff and VHSG volunteers as well as mothers' knowledge of newborn danger signs. However, further improvement in hygiene behavior among mothers and families will require involvement from broader stakeholders in the community. Trial Registration Number: ClinicalTrials.gov, Identifier: NCT02271737 Funding Statement: United States Agency for International Development under prime agreement number AID-OAAA-A-11-00012 with the National Academy of Sciences (NAS). Declaration of Interests: All authors declare that there are no conflicts of interest. Ethics Approval Statement: The trial protocol was approved by the National Ethics Committee Health Research of the Cambodia Ministry of Health and by the Institutional Review Boards of Tulane University.