Study site characteristics.

The study was carried out in Lagelu Local Government Area (LGA), Ibadan, Oyo State, Nigeria. The infant mortality rate is 41 per 1,000 live births and neonatal mortality rate of 30 per 1,000 live births for the State [5]. Proportions receiving antenatal care from a skilled provider, delivered in a health facility and delivered by a skilled provider are 85.4%, 70.1% and 84.6% respectively. Also, the proportion of children aged 12–23 months receiving all basic vaccinations is 23.3% while the percentage for all age-appropriate vaccinations is 16.6% [5].

Ibadan has 11 LGAs, five of which are urban and six are peri-urban and Lagelu is one of the 6 peri-urban LGAs. The estimated population of Lagelu is 150,000 [12]. It has 14 political wards which are the operating health units with each ward having a minimum of one Primary Health Care centre (PHC) or Health Post. Lagelu LGA was selected after extensive deliberations with Federal and Oyo state Ministries of Health (MOH), and other stakeholders because it has rural and peri-urban communities, relatively large size PHCs, Community Resource Persons (CORPs) are available and LGA administrators’ were ready to support the implementation. After further consultation with the health directorate, four wards (1, 4, 5 and 7) were selected, which were typical of rural communities where referral may not be feasible and had eight PHCs. The rural population are mainly Yoruba peasant farmers, petty traders and artisans with low income. Literacy level is low with the majority having a 6- years of education. Polygamous settings are common and most mothers have their health decisions influenced by husbands, co-wives, religious and traditional leaders and mothers- in-laws all playing the role of gate-keepers and significant others [13].

Health system structure.

Three levels of health structure operate in Nigeria; primary, secondary and tertiary and all three are available in Ibadan where sick infants from the selected LGA and wards are seen. The primary level is PHC under the health directorate of Local Government and State Ministry of Health, the smallest health care delivery unit serving a population of 5,000–6,000. It is located 1–2 kilometres from the communities. The services rendered are mainly outpatient with minimal or no admission facilities and reach the people through ward development health committees. The main role of PHC is to offer preventive and curative services. The PHCs are manned by doctors when available, nurses/midwives, Community Health Officers (CHOs) and Community Health Extension Workers (CHEWs). CORPs are used in community-based programmes dealing with maternal and child health, malarial drugs and insecticide-treated nets (ITN) distribution and are paid monthly stipend. CORPs minimum level of education is secondary school and most have been trained in integrated community case management (iCCM) [14] and home-based care of newborn. iCCM training materials were developed by WHO and UNICEF for the community level health workers to identify and refer common illnesses in under five-year-old children. Referral from PHC is to a secondary level general hospital, which is staffed with medical doctors and nurses. In some general hospitals, there may be specialist doctors trained in paediatrics or neonatology and may have a newborn nursery. Referral may also be to tertiary centres with specialized care. The referral centres for the LGA have newborn in-patient admission services including oxygen supply, parenteral antibiotics, and respiratory support but no family centred care.

Study population.

Young infants aged up to 2 months who had signs of PSBI identified at home and referred to PHC by CORPs or brought directly to the PHC by the caregivers.

Policy dialogue at national, state and local level.

In March 2015, a two-day orientation and policy dialogue meeting was held in Abuja, organised by the Federal MOH in collaboration with the WHO. Participants included senior federal and state MOH policymakers and programme implementers, representatives from the professional associations, stakeholders at national, sub-national levels and development partners, as well as WHO and UNICEF. The status of newborn and child health situation in Nigeria, programme strategies, evidence from the trials [3, 4, 8, 9] and WHO PSBI guideline [10] were presented and discussed. Meeting participants reviewed the research findings and discussed policy implications related to the implementation of the WHO PSBI guideline. It was decided to create a platform for learning through implementation research; to learn how the WHO PSBI guideline for managing young infants with PSBI when referral is not feasible can be implemented in a programme setting in Nigeria. It was agreed to set up two implementation research sites, one in Zaria, Kaduna State, Northern Nigeria [11] and the other in Ibadan, Oyo State, Southern Nigeria. Boxs 1 and 2 summarize the issues that were discussed and decisions made.

Box 1. Definitions and treatment of PSBI [10]

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Box 2. Policy dialogue decisions and recommendations

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Following the national and state-level dialogue, meetings with the Lagelu LGA chairman, senior administrators and the PHC coordinator were also held at their secretariat.

Community sensitization.

Several meetings were organized at the early phase with community leaders–local chiefs, religious leaders, market women and men associations, traditional birth attendants (TBA), and focal persons such as ward leaders and landlord associations. The number of such meetings varied from 3–5 per community served by the PHC and they were informed about the research and its potential benefits to the communities. These community leaders assisted in the selection of the CORPs using the following criteria: resident in the community, are available and can read and write with the minimum educational level of secondary school. These meetings ensured community acceptability of home visit in pregnancy and post-delivery follow up and their continuous involvement in the implementation of the study in their respective communities.

Establishment of a Technical Support Unit (TSU).

To kick start implementation, a TSU was set up at the University College Hospital, Ibadan and funded by the project. Members included the Principal Investigator, Project Manager, two Project Supervisors, eight Project Nurses, Executive Secretary of Oyo State Primary Health Care Board and a representative of the Local Government Health Directorate. All were master trainers for Integrated Management of Childhood Illnesses (IMCI), iCCM and training on Caring for the Newborn at Home [14, 16, 17]. The IMCI training materials were developed by WHO and UNICEF to manage common childhood illnesses for professional health workers working at first-level facilities or outpatient departments. This TSU was set up for the project and their funding ended with the project but the staff was available to share experiences and provide technical support for scale-up in other states. The role of the TSU is described in Box 3 below.

Box 3. Role of the technical support unit

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Preparations for the implementation of PSBI guideline.

Consultations were held between TSU staff and State MOH and PHC directorate in the public health system. Agreements were made between the two for collaboration and delineation of various tasks. The PHC directorate was to take part in facilitating the research, creating an enabling environment for health workers, ensuring routine and essential newborn care services and timely supply of commodities. They were also to promote and support post-natal home visits by CORPs, home visits by CORPs for infants who failed to present for follow up, ensure prompt and accurate record-keeping and facilitate the referral. The clinical staff [nurses, CHEWs, CHO] of the PHCs were to identify and classify sick young infants, refer to a hospital who needed it, reclassify if the referral was not feasible, treat and follow up those who were treated on an outpatient basis. The level of training, qualifications and responsibilities of these PHC health workers are described by Wammanda et al [11].

The potential cost for the involvement of CORPs, ensuring regular supply of drugs and commodities, purchase of medicines were also deliberated upon. Payment of stipend of 10,000 Nigerian Naira (approximately 33 US$) by the project fund to each CORP and bulk purchase of consumables especially medicines from local manufacturers were identified as means of reducing cost and ensuring a smooth implementation.

Situation analysis of sick newborn care and health facilities.

A situation analysis of the health facilities was conducted before the implementation of PSBI activities, which included a review of the availability of staff and their capacity at each PHC (S1 Table), facility leadership, supply chain, consumables inflow and outflow, sharps disposal and sick newborn registers. In general, all sick newborns and young infants were assessed at a PHC and referred from the LGA to either a secondary health facility, Oni Memorial Children’s Hospital; or tertiary facility, University College Hospital and Adeoyo Maternity Teaching Hospital in Ibadan city. The distance between the LGA and these facilities ranges between 10–40 km and the average cost of transportation is 600 Nigerian Naira (approximately 2 US$). At the PHC and these referral hospitals, cost of treatment is mainly out of pocket and occasionally medicines are subsidized through a revolving fund [18]. In the case of stockouts, patients had to buy medicines. Routine follow-up was not done to find out if a referral to a hospital was accepted or not. This management was in line with the iCCM or IMCI [14, 16, 17] strategies introduced and implemented in Nigeria.

Training of health workers.

Master Trainers were trained by WHO facilitators. TSU in collaboration with the LGA organized training for nurses and CORPS. CORPs received training on ‘Caring for the newborn at home’, a WHO/UNICEF training course for community health workers [17]. The study nurses, health facility nurses and CHEWs needed to have a broader understanding and hence were trained on ‘Caring for the newborn at home’ and the ‘Management of sick young infants aged up to 2 months’, a component of IMCI, WHO/UNICEF training module [19]. The 6 days training included theoretical knowledge, skills development using clinical practice at Oyo State Oni Memorial Children’s Hospital, games, role plays, interactive communication and group discussions. They were also trained on data collection using different case records forms. Multimedia, flip charts and training manuals were used. During and post-training skill acquisition was assessed through standardization exercises and field practice which included supervised hospital and home visits.

Tools and job aids.

The TSU adapted and updated tools and jobs aids including case record forms (CRFs), counselling cards, mother and baby card, referral notes, young infants IMCI Chart booklet and calendars for easy identification of dates for follow up. These were provided to the workers. When required health workers were provided with respiratory rate timers, digital thermometers, weighing scales, backpacks, mobile phones and umbrellas through project funds.

Logistics and commodities.

Oral amoxicillin dispersible tablets (DT), injectable gentamicin, 2 ml and 5 ml needles and syringes, cotton wool, methylated spirit and safety box were purchased in bulk locally through the project funds as these were not routinely supplied by the State and LGA. They were provided free of charge to the sick young infants with PSBI and the project was also responsible for cost of home visit.

Identification and management of sick young infants with PSBI.

Identification of live births. CORPs identified pregnancies and births through house-to-house visits, communication with pregnant mothers (who assisted in identifying other pregnant mothers), TBAs, health centres staff, community leaders and community spokespersons.

Identification of sick young infants and referral to PHC. CORPs made post-natal home visits on days 1, 2, 3, 7 and 14 days of birth to identify sick infants who needed to be referred to the PHC. Mothers were also counselled on signs of PSBI and prompt appropriate care-seeking.

Management of PSBI either at PHC or referral level facility. Each PHC had a trained HFW who examined the sick infant referred by the CORP or brought by the mother, sometimes assisted by the study nurse. Infants with signs of PSBI confirmed by HFW needing referral to a hospital were referred for appropriate treatment. However, when a referral was not feasible, further assessment and re-classification of the sick young infant were done by the HFW using the WHO young infant IMCI chart booklet [19] as a guide and prompt management was started according to the agreed protocol (Box 2). Mandatory follow up of sick infants on treatment was done at the PHC as described in Box 1 but those that did not come for follow up were visited at home by CORPs and study nurses. Treatment outcome of all sick infants was evaluated on day 14 of enrolment by study nurses while data on treatment adherence and follow up were collected by HFW and assisted by the study nurses.

Monitoring, supervision, skills maintenance and process evaluation.

To ensure quality, study supervisors performed routine visits starting with once a week per facility for health facility worker (HFW), three times a week per facility for the study nurses and daily for CORPs for direct observations using a monitoring form and a supervisory checklist (S1 File). Visits to HFWs included observation of assessment, classification and treatment of sick infants, retention of trained HFW, checking for implementation challenges and availability of commodities and job aids. Visits to study nurses included observing and checking the filling of IMCI assessment form and treatment form. Recording forms kept by CORPs were reviewed for correct filling of CRFs (pregnancy register and postnatal visit) and strict adherence to follow-up dates using the study calendar. The investigators also conducted random field visits to ensure internal quality control. Refresher training courses of various workers were conducted quarterly to ensure skills maintenance and quality standards. In-depth interview and focussed group discussions were conducted with mothers of sick young infants and Key Informant interview was conducted with the HFWs using standard interview guide by trained experts in qualitative research details of which will be published separately.

Consent and ethical approval.

The implementation research was approved by the Institutional Review Board of the University of Ibadan UI/EC/15/0177 and by the WHO Ethical Review Committee. Written informed consent was obtained from all eligible caregivers prior to their participation in the study.