Measuring coverage and quality of supportive care for inpatient neonatal infections: EN-BIRTH multi-country validation study.

Background: An estimated 7 million episodes of severe newborn infections occur annually worldwide, with half a million newborn deaths, most occurring in low- and middle-income countries. Whilst injectable antibiotics are necessary to treat the infection, supportive care is also crucial in ending preventable mortality and morbidity. This study uses multi-country data to assess gaps in coverage, quality, and documentation of supportive care, considering implications for measurement. Methods: The EN-BIRTH study was conducted in five hospitals in Bangladesh, Nepal, and Tanzania (July 2017-July 2018). Newborns with an admission diagnosis of clinically-defined infection (sepsis, meningitis, and/or pneumonia) were included. Researchers extracted data from inpatient case notes and interviews with women (usually the mothers) as the primary family caretakers after discharge. The interviews were conducted using a structured survey questionnaire. We used descriptive statistics to report coverage of newborn supportive care components such as oxygen use, phototherapy, and appropriate feeding, and we assessed the validity of measurement through survey-reports using a random-effects model to generate pooled estimates. In this study, key supportive care components were assessment and correction of hypoxaemia, hyperbilirubinemia, and hypoglycaemia. Results: Among 1015 neonates who met the inclusion criteria, 89% had an admission clinical diagnosis of sepsis. Major gaps in documentation and care practices related to supportive care varied substantially across the participating hospitals. The pooled sensitivity was low for the survey-reported oxygen use (47%; 95% confidence interval (CI) = 30%-64%) and moderate for phototherapy (60%; 95% CI = 44%-75%). The pooled specificity was high for both the survey-reported oxygen use (85%; 95% CI = 80%-89%) and phototherapy (91%; 95% CI = 82%-97%). Conclusions: The women's reports during the exit survey consistently underestimated the coverage of supportive care components for managing infection. We have observed high variability in the inpatient documents across facilities. A standardised ward register for inpatient small and sick newborn care may capture selected supportive care data. However, tracking the detailed care will require standardised individual-level data sets linked to newborn case notes. We recommend investments in assessing the implementation aspects of a standardised inpatient register in resource-poor settings.

Exploring health care seeking knowledge, perceptions and practices for childhood diarrhea and pneumonia and their context in a rural Pakistani community.

BACKGROUND: Where access to facilities for childhood diarrhea and pneumonia is inadequate, community case management (CCM) is an effective way of improving access to care. In Pakistan, utilization of CCM for these diseases through the Lady Health Worker Program remains low. Challenges of access to facilities persist leading to delayed care and poor outcomes. Estimating caregiver knowledge, understanding their perceptions and practices, and recognizing how these are related to care seeking decisions about childhood diarrhea and pneumonia is crucial to bring about coherence between supply and demand-side practices. METHODS: Data was collected from family caregivers to explore their knowledge, perceptions and practices regarding childhood diarrhea and pneumonia. Data from a household survey with 7025 caregivers, seven focus group discussion (FGDs), seven in-depth interviews (IDIs), and 20 detailed narrative interviews are used to explore caregiver knowledge, perceptions and practices. RESULTS: Household survey shows that most family caregivers recognize main signs and symptoms of diarrhea such as loose stools (76%). Fewer recognize signs and symptoms of pneumonia such as breathing problems (21%). Few caregivers (18%) have confidence in lady health workers' (LHWs) ability to treat childhood diarrhea and pneumonia. Care seeking from LHWs remains negligible (< 1%). Caregivers overwhelmingly prefer to seek care from doctors (97%). Seventy-five percent caregivers sought care from private providers and 45% from public providers. FGDs, IDIs, and narrative interviews show that care mostly begins with home remedies and sometimes self-prescribed medicines. Treatment delays occur because of caregiver inability to recognize disease, use of home remedies, financial constraints, and low utilization of community based LHW services. Caregivers do not seek care from LHWs because of lack of trust and LHWs' inability to provide medicines. If finances allow, private doctors, who caregivers perceive as more responsive, are preferred over public sector doctors. Financial resources, availability of time, support for household chores by family and community determine whether, when, and from whom caregivers seek care. CONCLUSIONS: Many children do not receive recommended diarrhea and pneumonia treatment on time. Taking into consideration caregiver concerns, adequate supply of medicines to LHWs, improved facility level care could improve care seeking practices and child health outcomes. TRIAL REGISTRATION: The trial is registered with 'Australian New Zealand Clinical Trials Registry'. Registration Number: ACTRN12613001261707 . Registered 18 November 2013.

Improving oxygen therapy for children and neonates in secondary hospitals in Nigeria: study protocol for a stepped-wedge cluster randomised trial.

BACKGROUND: Oxygen is a life-saving, essential medicine that is important for the treatment of many common childhood conditions. Improved oxygen systems can reduce childhood pneumonia mortality substantially. However, providing oxygen to children is challenging, especially in small hospitals with weak infrastructure and low human resource capacity. METHODS/DESIGN: This trial will evaluate the implementation of improved oxygen systems at secondary-level hospitals in southwest Nigeria. The improved oxygen system includes: a standardised equipment package; training of clinical and technical staff; infrastructure support (including improved power supply); and quality improvement activities such as supportive supervision. Phase 1 will involve the introduction of pulse oximetry alone; phase 2 will involve the introduction of the full, improved oxygen system package. We have based the intervention design on a theory-based analysis of previous oxygen projects, and used quality improvement principles, evidence-based teaching methods, and behaviour-change strategies. We are using a stepped-wedge cluster randomised design with participating hospitals randomised to receive an improved oxygen system at 4-month steps (three hospitals per step). Our mixed-methods evaluation will evaluate effectiveness, impact, sustainability, process and fidelity. Our primary outcome measures are childhood pneumonia case fatality rate and inpatient neonatal mortality rate. Secondary outcome measures include a range of clinical, quality of care, technical, and health systems outcomes. The planned study duration is from 2015 to 2018. DISCUSSION: Our study will provide quality evidence on the effectiveness of improved oxygen systems, and how to better implement and scale-up oxygen systems in resource-limited settings. Our results should have important implications for policy-makers, hospital administrators, and child health organisations in Africa and globally. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12617000341325 . Retrospectively registered on 6 March 2017.

Ending preventable child deaths from pneumonia and diarrhoea by 2025. Development of the integrated Global Action Plan for the Prevention and Control of Pneumonia and Diarrhoea.

Despite the existence of low-cost and effective interventions for childhood pneumonia and diarrhoea, these conditions remain two of the leading killers of young children. Based on feedback from health professionals in countries with high child mortality, in 2009, WHO and Unicef began conceptualising an integrated approach for pneumonia and diarrhoea control. As part of this initiative, WHO and Unicef, with support from other partners, conducted a series of five workshops to facilitate the inclusion of coordinated actions for pneumonia and diarrhoea into the national health plans of 36 countries with high child mortality. This paper presents the findings from workshop and post-workshop follow-up activities and discusses the contribution of these findings to the development of the integrated Global Action Plan for the Prevention and Control of Pneumonia and Diarrhoea, which outlines the necessary actions for elimination of preventable child deaths from pneumonia and diarrhoea by 2025. Though this goal is ambitious, it is attainable through concerted efforts. By applying the lessons learned thus far and continuing to build upon them, and by leveraging existing political will and momentum for child survival, national governments and their supporting partners can ensure that preventable child deaths from pneumonia and diarrhoea are eventually eliminated.

Bottlenecks, barriers, and solutions: results from multicountry consultations focused on reduction of childhood pneumonia and diarrhoea deaths.

Millions of children still die unnecessarily from pneumonia and diarrhoea, mainly in resource-poor settings. A series of collaborative consultations and workshops involving several hundred academic, public health, governmental and private sector stakeholders were convened to identify the key barriers to progress and to issue recommendations. Bottlenecks impairing access to commodities included antiquated supply management systems, insufficient funding for drugs, inadequate knowledge about interventions by clients and providers, health worker shortages, poor support for training or retention of health workers, and a failure to convert national policies into action plans. Key programmatic barriers included an absence of effective programme coordination between and within partner organisations, scarce financial resources, inadequate training and support for health workers, sporadic availability of key commodities, and suboptimal programme management. However, these problems are solvable. Advocacy could help to mobilise needed resources, raise awareness, and prioritise childhood pneumonia and diarrhoea deaths in the coming decade.

Disease profile of children under 5 years attending primary health care clinics in a high HIV prevalence setting in South Africa.

OBJECTIVE: To describe the presenting complaints and disease profile of children attending primary health care (PHC) clinics in two provinces of South Africa. METHODS: Participants were sick children 2-59 months old presenting for care at PHC clinics in KwaZulu-Natal (KZN) and Limpopo provinces from 2006-2007. Children were assessed by an expert Integrated Management of Childhood Illnesses (IMCI) practitioner. Children for whom parental/guardian consent was obtained were tested for HIV. RESULTS: A total of 1357 children attending one of 74 clinics were assessed. HIV seroprevalence overall was 7.1%, but was significantly higher in KZN than Limpopo (7.5 vs. 2.4%; OR = 3.3, 95%CI 1.9-5.8%). Commonest presenting complaints were cough (72%), skin conditions (22%) and diarrhoea (19%). Of 1349 children, 120 (8.9%) had a weight below the third percentile; 108/1357 (8.0%) children required urgent referral, most commonly for severe pneumonia (53.7%) and severe malnutrition (16.7%). In multivariate analyses, severe pneumonia, growth faltering and urgent referral were independently associated with younger age, residence in KZN and HIV infection (P < 0.05). CONCLUSIONS: Many children with severe illnesses and undiagnosed HIV infection present to PHC facilities. PHC staff require skills to correctly manage these conditions and undertake HIV testing. Although IMCI provides evidence-based guidelines, implementation must be improved to achieve adequate coverage of life-saving interventions.

Routine checks for HIV in children attending primary health care facilities in South Africa: attitudes of nurses and child caregivers.

Management of HIV-infected and exposed children is challenging for health workers in primary care settings. Integrated management of childhood illness (IMCI) is a WHO/UNICEF strategy for improving morbidity and mortality in under 5 children attending first level facilities in developing countries. In high HIV-prevalence settings, IMCI includes an HIV component for identification and management of HIV-infected and exposed children, which requires health workers to ask all mothers about their HIV status and check all children for signs of HIV. Effective implementation of the HIV component depends on the ability and willingness of health workers to take every opportunity to identify HIV-infected children during routine care, and implementation in South Africa is poor. In 2006, we conducted 10 focus groups in two provinces in South Africa with IMCI-trained nurses, and with mothers attending first level facilities, to determine their attitudes towards, and experiences of, routine checks for HIV during consultations with sick children. Nurses were frequently unwilling to check for HIV in all children, believing it was unnecessary, unacceptable to mothers, and that they lack skills to implement HIV care. Nurses feared mothers would become upset or make a complaint. Mothers consistently recognised the importance of checking children for HIV and supported implementation of routine checks, although the attitude of the nurse was important in determining the acceptability of HIV-related questions. Mothers expressed fears about lack of confidentiality from nurses, and that receiving HIV-related services could lead to unintentional disclosure of their HIV status. Nurses lack the skills in HIV management and communication skills to implement the HIV component of IMCI. We identify issues relate to improved training, clear policies on record keeping, and organization of health services to respect privacy and confidentiality, to improve the willingness of health workers to provide HIV care and mothers to accept it.

Experiences of training and implementation of integrated management of childhood illness (IMCI) in South Africa: a qualitative evaluation of the IMCI case management training course.

BACKGROUND: Integrated Management of Childhood Illness (IMCI) is a strategy to reduce mortality and morbidity in children under-5 years by improving management of common illnesses at primary level. IMCI has been shown to improve health worker performance, but constraints have been identified in achieving sufficient coverage to improve child survival, and implementation remains sub-optimal. At the core of the IMCI strategy is a clinical guideline whereby health workers use a series of algorithms to assess and manage a sick child, and give counselling to carers. IMCI is taught using a structured 11-day training course that combines classroom work with clinical practise; a variety of training techniques are used, supported by comprehensive training materials and detailed instructions for facilitators. METHODS: We conducted focus group discussions with IMCI trained health workers to explore their experiences of the methodology and content of the IMCI training course, whether they thought they gained the skills required for implementation, and their experiences of follow-up visits. RESULTS: Health workers found the training interesting, informative and empowering, and there was consensus that it improved their skills in managing sick children. They appreciated the variety of learning methods employed, and felt that repetition was important to reinforce knowledge and skills. Facilitators were rated highly for their knowledge and commitment, as well as their ability to identify problems and help participants as required. However, health workers felt strongly that the training time was too short to acquire skills in all areas of IMCI. Their increased confidence in managing sick children was identified by health workers as an enabling factor for IMCI implementation in the workplace, but additional time required for IMCI consultations was expressed as a major barrier. Although follow-up visits were described as very helpful, these were often delayed and there was no ongoing clinical supervision. CONCLUSION: The IMCI training course was reported to be an effective method of acquiring skills, but more time is required, either during the course, or with follow-up, to improve IMCI implementation. Innovative solutions may be required to ensure that adequate skills are acquired and maintained.

Paediatric HIV management at primary care level: an evaluation of the integrated management of childhood illness (IMCI) guidelines for HIV.

BACKGROUND: Integrated Management of Childhood Illness (IMCI) is a WHO/UNICEF strategy to improve child survival in resource poor settings. South Africa adopted IMCI in 1997, and IMCI guidelines were adapted to include identification and management of HIV infected and exposed children. This study describes the validity of the IMCI/HIV algorithm when used by IMCI experts, the use of IMCI/HIV guidelines by IMCI trained health workers in routine clinical practice, and the burden of HIV among children under 5 years attending first level health facilities. METHODS: Seventy seven randomly selected IMCI trained health workers were observed in 74 health facilities in two provinces of South Africa. Consultations were observed with 1357 sick children; each child was reassessed by an IMCI expert to confirm the correct findings. Consent was requested for HIV testing of all children who attended with a parent or legal guardian. Positive rapid HIV tests were confirmed with HIV PCR in children aged less than 18 months. HIV positive children had a CD4 count and HIV clinical staging done. RESULTS: Of 1064 children with HIV results available, 76 (7.1% CI: 5.7% - 8.9%) children were confirmed HIV positive. IMCI experts using the HIV algorithm classified 54/76 (71.1% CI: 59.5%-80.9%) HIV positive children as suspected symptomatic HIV, and 15/22 remaining HIV positive children were identified as HIV exposed. Therefore, 69/76 (90.8% CI: 81.9-96.2) HIV infected children were identified by IMCI experts. No classification was made for HIV by observed health workers in 899/1357(66.2%) children.906/1243(72.9%) mothers had been tested previously for HIV, of whom 221(24.4%) reported testing positive. Of 221 children therefore identified as HIV exposed, only 78(35.3%) had been tested for HIV within routine services. CONCLUSION: The HIV algorithm is a valid tool for identifying HIV infected and exposed children when correctly and comprehensively implemented. However, it is not being used by IMCI trained health workers in routine practise, leading to a failure to implement life saving interventions.

An evaluation of the quality of IMCI assessments among IMCI trained health workers in South Africa.

BACKGROUND: Integrated Management of Childhood Illness (IMCI) is a strategy to reduce mortality and morbidity in children under 5 years by improving case management of common and serious illnesses at primary health care level, and was adopted in South Africa in 1997. We report an evaluation of IMCI implementation in two provinces of South Africa. METHODOLOGY/PRINCIPAL FINDINGS: Seventy-seven IMCI trained health workers were randomly selected and observed in 74 health facilities; 1357 consultations were observed between May 2006 and January 2007. Each health worker was observed for up to 20 consultations with sick children presenting consecutively to the facility, each child was then reassessed by an IMCI expert to determine the correct findings. Observed health workers had been trained in IMCI for an average of 32.2 months, and were observed for a mean of 17.7 consultations; 50/77(65%) HW's had received a follow up visit after training. In most cases health workers used IMCI to assess presenting symptoms but did not implement IMCI comprehensively. All but one health worker referred to IMCI guidelines during the period of observation. 9(12%) observed health workers checked general danger signs in every child, and 14(18%) assessed all the main symptoms in every child. 51/109(46.8%) children with severe classifications were correctly identified. Nutritional status was not classified in 567/1357(47.5%) children. CONCLUSION/SIGNIFICANCE: Health workers are implementing IMCI, but assessments were frequently incomplete, and children requiring urgent referral were missed. If coverage of key child survival interventions is to be improved, interventions are required to ensure competency in identifying specific signs and to encourage comprehensive assessments of children by IMCI practitioners. The role of supervision in maintaining health worker skills needs further investigation.

Recommendations for treatment of childhood non-severe pneumonia.

WHO recommendations for early antimicrobial treatment of childhood pneumonia have been effective in reducing childhood mortality, but the last major revision was over 10 years ago. The emergence of antimicrobial resistance, new pneumonia pathogens, and new drugs have prompted WHO to assemble an international panel to review the literature on childhood pneumonia and to develop evidence-based recommendations for the empirical treatment of non-severe pneumonia among children managed by first-level health providers. Treatment should target the bacterial causes most likely to lead to severe disease, including Streptoccocus pneumoniae and Haemophilus influenzae. The best first-line agent is amoxicillin, given twice daily for 3-5 days, although co-trimoxazole may be an alternative in some settings. Treatment failure should be defined in a child who develops signs warranting immediate referral or who does not have a decrease in respiratory rate after 48-72 h of therapy. If failure occurs, and no indication for immediate referral exists, possible explanations for failure should be systematically determined, including non-adherence to therapy and alternative diagnoses. If failure of the first-line agent remains a possible explanation, suitable second-line agents include high-dose amoxicillin-clavulanic acid with or without an affordable macrolide for children over 3 years of age.

Ambulatory short-course high-dose oral amoxicillin for treatment of severe pneumonia in children: a randomised equivalency trial.

BACKGROUND: WHO case management guidelines for severe pneumonia involve referral to hospital for treatment with parenteral antibiotics. If equally as effective as parenteral treatment, home-based oral antibiotic treatment could reduce referral, admission, and treatment costs. Our aim was to determine whether home treatment with high-dose oral amoxicillin and inpatient treatment with parenteral ampicillin were equivalent for the treatment of severe pneumonia in children. METHODS: This randomised, open-label equivalency trial was done at seven study sites in Pakistan. 2037 children aged 3-59 months with severe pneumonia were randomly allocated to either initial hospitalisation and parenteral ampicillin (100 mg/kg per day in four doses) for 48 h, followed by 3 days of oral amoxicillin (80-90 mg/kg per day; n=1012) or to home-based treatment for 5 days with oral amoxicillin (80-90 mg/kg per day in two doses; n=1025). Follow-up assessments were done at 1, 3, 6, and 14 days after enrollment. The primary outcome was treatment failure (clinical deterioration) by day 6. Analyses were done per protocol and by intention to treat. This trial is registered, ISRCTN95821329. FINDINGS: In the per-protocol population, 36 individuals were excluded from the hospitalised group and 37 from the ambulatory group, mainly because of protocol violations or loss to follow-up. There were 87 (8.6%) treatment failures in the hospitalised group and 77 (7.5%) in the ambulatory group (risk difference 1.1%; 95% CI -1.3 to 3.5) by day 6. Five (0.2%) children died within 14 days of enrollment, one in the ambulatory group and four in the hospitalised group. In each case, treatment failure was declared before death and the antibiotic had been changed. None of the deaths were considered to be associated with treatment allocation; there were no serious adverse events reported in the trial. INTERPRETATION: Home treatment with high-dose oral amoxicillin is equivalent to currently recommended hospitalisation and parenteral ampicillin for treatment of severe pneumonia without underlying complications, suggesting that WHO recommendations for treatment of severe pneumonia need to be revised.

Direct detection of the multidrug resistance genome of Haemophilus influenzae in cerebrospinal fluid of children: implications for treatment of meningitis.

BACKGROUND: Multidrug resistance (MDR), specifically to ampicillin and chloramphenicol, has complicated the treatment of Haemophilus influenzae type b (Hib) meningitis. This is worsened by use of prior antibiotics, which limits identification of the causative agent by culture and increases reliance on antigen detection. OBJECTIVE: We aimed to develop a PCR assay for detecting the family of Haemophilus integrating and conjugative elements (ICEs) represented by ICEHin1056 among antibiotic resistant Hib, and then apply this directly to CSF to diagnose Hib meningitis and predict organism susceptibility, irrespective of culture results. STUDY DESIGN: Primers specific for orf 51 of ICEHin1056 were designed and multiplexed with Bex primers, specific for H. influenzae, and tested on culture positive and negative cases. RESULTS: Of 73 Hib isolates, orf 51 PCR amplicons, predicting the presence of ICEs, were found in all 33 MDR isolates while only in 1 of 33 sensitive strains. The remaining 7 ampicillin susceptible, chloramphenicol and tetracycline resistant strains did not produce a PCR product to orf 51. PCR amplification from CSF specimens of these culture positive cases produced identical results with 100% and 97% positive and negative predictive values, respectively. Multiplex PCR to detect Bex and orf 51 identified another 16 MDR Hib cases among 81 culture-negative CSF samples. CONCLUSIONS: Direct PCR for orf 51 in CSF identified resistance pattern of 51% more Hib strains than culture alone (110 versus 73). The ability to detect MDR, in culture negative Hib meningitis cases has significant implications for better directing antibiotic treatment of meningitis cases and thus for preventing disability and death.