Prospective cohort study of referred Malawian children and their survival by hypoxaemia and hypoglycaemia status

Objective To investigate survival in children referred from primary care in Malawi, with a focus on hypoglycaemia and hypoxaemia progression. Methods The study involved a prospective cohort of children aged 12 years or under referred from primary health-care facilities in Mchinji district, Malawi in 2019 and 2020. Peripheral blood oxygen saturation (SpO2) and blood glucose were measured at recruitment and on arrival at a subsequent health-care facility (i.e. four hospitals and 14 primary health-care facilities). Children were followed up 2 weeks after discharge or their last clinical visit. The primary study outcome was the case fatality ratio at 2 weeks. Associations between SpO2 and blood glucose levels and death were evaluated using Cox proportional hazards models and the treatment effect of hospitalization was assessed using propensity score matching. Findings Of 826 children recruited, 784 (94.9%) completed follow-up. At presentation, hypoxaemia was moderate (SpO2: 90­93%) in 13.1% (108/826) and severe (SpO2: < 90%) in 8.6% (71/826) and hypoglycaemia was moderate (blood glucose: 2.5­4.0 mmol/L) in 9.0% (74/826) and severe (blood glucose: < 2.5 mmol/L) in 2.3% (19/826). The case fatality ratio was 3.7% (29/784) overall but 26.3% (5/19) in severely hypoglycaemic children and 12.7% (9/71) in severely hypoxaemic children. Neither moderate hypoglycaemia nor moderate hypoxaemia was associated with mortality. Conclusion Presumptive pre-referral glucose treatment and better management of hypoglycaemia could reduce the high case fatality ratio observed in children with severe hypoglycaemia. The morbidity and mortality burden of severe hypoxaemia was high; ways of improving hypoxaemia identification and management are needed.

Community case management of chest indrawing pneumonia in children aged 2 to 59 months by community health workers: study protocol for a multi-country cluster randomized open label non-inferiority trial

Background:The World Health Organization (WHO) integrated management of childhood illness (IMCI) protocol recommends treatment of chest indrawing in 2-59 months old children with oral amoxicillin by trained health facility workers. Whereas, the WHO/UNICEF integrated community case management (iCCM) protocol recommends referral by community level health workers (CLHWs) to a health facility. This study aims to evaluate whether CLHWs can treat chest indrawing pneumonia effectively and safely.Methods:Thismulti-centre cluster randomized controlled open label, non-inferiority trial will be conductedin Bangladesh, Ethiopia, India and Malawi. All sites will use a common protocol with the same study design, participants, intervention, control and outcomes. CLHWs will identify 2-59 months old children with chest indrawing. Study supervisors, trained in the iCCM protocol, will confirm CLHWs’ findings. Pulse oximetry will be used to identify hypoxaemic children. In the intervention group, enrolled children will be treated with oral amoxicillin for 5 days, and in the control group they will be referred to ahealth facility, after providing first dose of oral amoxicillin. An independent outcome assessor will visit each enrolled child on days 6 and 14 of enrolment, to assess study outcomes.Conclusions:If CLHWs can effectively and safely treat chest indrawing pneumonia in 2-59 months old children, it will increase access to pneumonia treatment substantially, as in many settings, health facilities and trained health workers are not easily accessible. Moreover, this evidence will contribute towards the review of the current iCCM protocol and its harmonization with the IMCI protocol. Trial Registration:The trial is registered at AZNCTR International Trial Registry as ACTRN12617000857303

Management of fast breathing pneumonia in young infants aged 7 to 59 days by community level health workers: protocol for a multi-centre cluster randomized controlled trial

Background:WHO does not recommend community-level health workers (CLHWs) using integrated community case management (iCCM) to treat 7-59 days old infants with fast breathing with oral amoxicillin, whereas World Health Organization (WHO)integrated management of childhood illness (IMCI) recommends it. We want to collect evidence to help harmonization of both protocols.Methods:A cluster, randomized, open-label trial will be conducted in Africa and Asia (Ethiopia, Malawi, Bangladesh and India) using a common protocol with the same study design, inclusion criteria, intervention, comparison, and outcomes to contribute to the overall sample size. This trial will also identify hypoxaemia in young infants with fast breathing. CLHWs will assess infants for fast breathing, which will be confirmed by a study supervisor. Enrolled infants in the intervention clusters will be treated with oral amoxicillin, whereas in the control clusters they will be managed as per existing iCCM protocol. An independent outcome assessor will assess all enrolled infants on days 6 and 14 of enrolment for the study outcomes in both intervention and control clusters. Primary outcome will be clinical treatment failure by day 6. This trial will obtain approval from the WHO and site institutional ethics committees. Conclusions: If the research shows that CLHWs can effectively and safely treat fast breathing pneumonia in 7-59 days old young infants, it will increase access to pneumonia treatment substantially for infants living in communities with poor access to health facilities. Additionally, this evidence will contribute towards the review of the current iCCM protocol and its harmonization with IMCI protocol.Trial Registration:The trial is registered at AZNCTR International Trial Registry as ACTRN12617000857303.

Are we adequately managing children with wheeze using the standard case management guidelines?

INTRODUCTION: Prevalence of wheezing is increasing, bronchodilators are sub-optimally utilized and antibiotics are over-prescribed. In Thailand, current case management guidelines based on WHO guidelines, recommend two doses of rapid-acting bronchodilator for children with audible wheeze and fast breathing (FB) and/or lower chest indrawing (LCI). OBJECTIVE: To document the response of children with wheeze with FB and/or LCI to up to three doses of bronchodilator therapy and followed children whose FB and LCI disappeared for 7 days. MATERIAL AND METHOD: We documented response to up to three dose of inhaled salbutamol in consecutively assessed eligible children 1-59 months of age presenting with auscultatory/audible wheeze and FB [WHO defined non-severe pneumonia (NSP)] and/or LCI [WHO defined severe pneumonia (SP)] at the outpatient department of a referral hospital. Data were collected for up to 7 days in responders to bronchodilator therapy. RESULTS: Of 534 children were screened from November 2001 to February 2003, 263 (49.3%) had wheeze and NSP and 271 (50.7%) had wheeze and SP Forty-eight children (9%) had audible wheeze. At screening, 224/263 (85.2%) children in the NSP group and 195/271 (72.0%) in the SP group responded to inhaled salbutamol. 86/419 (20.5%) responded to the third dose of bronchodilator Four hundred and nineteen responders were enrolled and followed up. On follow-up, 14/217 (6.5%) responders among the NSP group and 24/190 (12.6%) among the SP group showed deterioration. Age 1-11 months at screening was identified as an independent predictor of subsequent deterioration. Two seasonal peaks from December to March and from August to October were documented. CONCLUSION: A third dose of bronchodilator therapy at screening will improve the specificity of case management guidelines and reduce antibiotic use. Physicians should use auscultation for management of wheeze.