Implementation of an innovative approach to jump start simplified management of sick young infants with possible serious bacterial infection (PSBI) where referral is not feasible for potential scale-up

WHO developed a guideline ‘managing possible serious bacterial infection in young infants when referral is not feasible’ in 2015. This guideline will make treatment more accessible and acceptable to families, as well as easier and less costly for the system to implement, when referral is not feasible. Following are the WHO recommendations on managing PSBI in young infants 0-59 days old when families do not accept or cannot access referral care: 1. Community health workers and home visits for postnatal care: At home visits made as part of postnatal care, community health workers should counsel families on recognition of danger signs, assess young infants for danger signs of illness and promote appropriate care seeking. Community health workers should conduct once every week for 2 months post birth. 2. Infants 0–6 days with fast breathing as the only sign of illness: Young infants 0–6 days old with fast breathing as the only sign of illness should be referred to hospital. If families do not accept or cannot access referral care, these infants should be treated with oral amoxicillin, 50 mg/kg per dose twice daily for seven days, by an appropriately trained health worker. 3. Infants 7–59 days with fast breathing as the only sign of illness: Young infants 7–59 days old with fast breathing as the only sign of illness should be treated with oral amoxicillin, 50 mg/kg per dose twice daily for seven days, by an appropriately trained health worker. These infants do not need referral. 4. Young infants 0–59 days old with clinical severe infection: Young infants 0–59 days old with clinical severe infection whose families do not accept or cannot access referral care should be managed in outpatient settings by an appropriately trained health worker with one of the following regimens: Option 1: Intramuscular gentamicin 5–7.5 mg/kg (for low-birth-weight infants gentamicin 3–4 mg/kg) once daily for seven days and twice daily oral amoxicillin, 50 mg/kg per dose for seven days. Close follow-up is essential. Option 2: Intramuscular gentamicin 5–7.5 mg/kg (for low-birth-weight infants gentamicin 3–4 mg/kg) once daily for two days and twice daily oral amoxicillin, 50 mg/kg per dose for seven days. Close follow-up is essential. A careful assessment on day 4 is mandatory. 5. Young infants 0–59 days old with critical illness: Young infants 0–59 days old who have any sign of critical illness (at presentation or developed during treatment of clinical severe infection) should be hospitalized after pre-referral treatment (Pre-referral treatment: Give first dose of both ampicillin (50 mg/kg per dose) or benzyl penicillin (50000 units/kg per dose) and gentamicin (5–7.5 mg/kg per dose) intramuscularl). We propose an implementation research for the implementation of an innovative approach to spearhead facilitated policy adoption and readiness for scale up for routine use of simplified management of sick young infants with possible serious bacterial infection (PSBI) where referral is not feasible through the following. • Policy dialogue and orientation meetings held at national level with Ministry of Health (MOH) and other stakeholders at national and sub-national level to discuss limited policy adoption to set up demonstration sites to deliver this intervention and potential scale-up in programme setting. • Demonstration sites established in the five countries to demonstrate feasibility of delivering simplified antibiotic regimens to young infants with PSBI where referral is not feasible and following them till day 14 for outcome; and develop a partnership with programme managers to provide technical assistance to initiate a pilot in a few health facilities in programme setting. Demonstration sites are first level public health facilities. The intervention will be deliver in a routine setting at first level care facilities in the participating countries. Routine monitoring and supervision through Department/Ministry of Health will continue. The health workers will be trained by the Ministry of Health in these guidelines before the commencement of actual enrolment. Data will be extracted from the routine patient registration forms placed at the participating centres. The outcome will be assessed as number of young infants with PSBI refusing referral advice to the hospital during the study period. The exact medication regimen administered to each patient who does not require/accept referral will be at the clinical discretion of the treating health worker. The duration of intervention will be 18 months at each site. The young infant IMCI materials will be revised to include the new WHO recommendations for PSBI. These include a chart booklet, a facilitator’s guide, participant training manual, data collection instruments and other ancillary documents. A training of trainers’ (TOT) for revised young infant component of IMCI will be held in each country. It will be facilitated by WHO and IMCI master trainers in each country. Participants will be trained on revised IMCI modules for sick young infants during the first 3 days and the fourth day will be used to review site preparation and review the implementation research study materials. Master trainers trained in training of trainers will impart a 7-day training to health workers posted at the first level health facility to identify young infants with PSBI. It contains classroom training as well as clinical sessions. A one-day refresher training will be given to physicians also. In each training batch 20-25 health workers will be trained.