Abstract

BackgroundNeonatal infections are a leading cause of mortality globally. They should ideally be treated in a hospital. However, in resource constraint settings refusal to hospitalization is high. To address this, the World Health Organization (WHO) developed a guideline for managing Possible Serious Bacterial Infections (PSBI) on an outpatient basis when referral to a hospital is not feasible. The objective of this research was to achieve high coverage of PSBI treatment and evaluate enablers and barriers to implementation of WHO guideline. Methods: We implemented the WHO PSBI guideline in the programme setting at 10 Basic Health Units (BHU) in two rural districts of Sindh (Thatta and Sujawal) in Pakistan using implementation research. We conducted policy dialogue with federal and provincial decision-makers and held discussions with programme managers and community leaders. A Technical Supporting Unit supported the programme to operationalize guidelines, capacity building of health workers, monitored their skills and mentored them and assured quality. The community-based health workers visited households to identify sick infants and referred them to the nearest BHU for further management. Data was collected by the research team. Results: Of 17,600 identified births, 1860 young infants with any sign of PSBI sought care at study BHUs and 1113 (59.8%) were brought by families. We achieved treatment coverage of 95%, assuming an estimated 10% incidence of PSBI in the first two months of life and that 10% of young infants came from outside the study catchment area. A total of 923 infants (49%; 923/1860) 7-59 days old with only fast breathing (pneumonia) were treated with oral amoxicillin without referral and all survived. A hospital referral was offered to 937 young infants, but 781 families (83.4%, 781/937) refused and accepted outpatient treatment. Among 344 (18.5%; 344/1860) <7 days old young infants with severe pneumonia, 335 (97.4%; 335/344) received outpatient treatment, 24 (7.2%; 24/335) failed treatment while one died. Among 495 (26.6%; 495/1860) with clinical severe infection 440 (88.9%; 440/495) received outpatient treatment, 34 (7.7%; 34/440) failed treatment, whereas 4 (0.9%; 4/440) died. Among 98 (4.9%; 98/1860) infants with critical illness, 6 (6.1%; 6/98) refused referral and received outpatient treatment, 3 (50%; 3/6)) failed treatment and one died. Twelve (7.6%; 12/156) deaths were recorded amongst those treated in a hospital. Conclusion: It is feasible to implement WHO PSBI management guidelines in a programmatic setting when a referral is not feasible. However, a scale-up of the guideline will require strong government commitment, system strengthening and capacity building of health workers along with adequate supervision and monitoring. Trial Registration: The trial is registered on the Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12617001373369. Funding: This study was funded by the Bill and Melinda Gates Foundation to the Department of Maternal, Newborn, Child and Adolescent Health, World Health Organization, Geneva, Switzerland through grant number OPP1114815. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Declaration of Interest: The authors have declared that no competing interests exist. Ethical Approval: This study was approved by the AKU Ethical Review Committee (ERC Number: 3936-Ped-ERC-15) and WHO Research Ethics Review Committee. Caregivers of infants provided informed, signed consent before enrolment in the study. Those who were unable to sign provided a thumb impression to express consent.

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