Bubble continuous positive airway pressure for children with high-risk conditions and severe pneumonia in Malawi: an open label, randomised, controlled trial

By Eric D McCollum, Tisungane Mvalo, Michelle Eckerle, Andrew G Smith, Davie Kondowe, Don Makonokaya, Dhananjay Vaidya, Veena Billioux, Alfred Chalira, Norman Lufesi, Innocent Mofolo, Mina Hosseinipour

The Lancet Respiratory Medicine. September 24, 2019

 

Pneumonia is the leading cause of death among children globally. Most pneumonia deaths in low-income and middle-income countries (LMICs) occur among children with HIV infection or exposure, severe malnutrition, or hypoxaemia despite antibiotics and oxygen. Non-invasive bubble continuous positive airway pressure (bCPAP) is considered a safe ventilation modality that might improve child pneumonia survival. bCPAP outcomes for high-risk African children with severe pneumonia are unknown. Since most child pneumonia hospitalisations in Africa occur in non-tertiary district hospitals without daily physician oversight, we aimed to examine whether bCPAP improves severe pneumonia mortality in such settings. This open-label, randomised, controlled trial was done in the general paediatric ward of Salima District Hospital, Malawi. We enrolled children aged 1–59 months old with WHO-defined severe pneumonia and either HIV infection or exposure, severe malnutrition, or an oxygen saturation of less than 90%. Children were randomly assigned 1:1 to low-flow nasal cannula oxygen or nasal bCPAP. Non-physicians administered care; the primary outcome was hospital survival. Primary analyses were by intention-to-treat and interim and adverse events analyses per protocol. This trial is registered with ClinicalTrials.gov, number NCT02484183, and is closed. We screened 1712 children for eligibility between June 23, 2015, and March 21, 2018. The data safety and monitoring board stopped the trial for futility after 644 of the intended 900 participants were enrolled. 323 children were randomly assigned to oxygen and 321 to bCPAP. 35 (11%) of 323 children who received oxygen died in hospital, as did 53 (17%) of 321 who received bCPAP (relative risk 1·52; 95% CI 1·02–2·27; p=0·036). 13 oxygen and 17 bCPAP patients lacked hospital outcomes and were considered lost to follow-up. Suspected adverse events related to treatment occurred in 11 (3%) of 321 children receiving bCPAP and 1 (<1%) of 323 children receiving oxygen. Four bCPAP and one oxygen group deaths were classified as probable aspiration episodes, one bCPAP death as probable pneumothorax, and six non-death bCPAP events included skin breakdown around the nares. bCPAP treatment in a paediatric ward without daily physician supervision did not reduce hospital mortality among high-risk Malawian children with severe pneumonia, compared with oxygen. The use of bCPAP within certain patient populations and non-intensive care settings might carry risk that was not previously recognised. bCPAP in LMICs needs further evaluation before wider implementation for child pneumonia care.

 

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Feeding during High-Flow Nasal Cannula for Bronchiolitis: Associations with Time to Discharge

By Kristin A Shadman, Michelle M Kelly, M Bruce Edmonson, Daniel J Sklansky, Kirstin Nackers, Ann Allen, Christina B Barreda, Anne S Thurber, Ryan J Coller. Published in The Journal of Hospital Medicine. September 18, 2019.  

 

High-flow nasal cannula (HFNC) is increasingly used to treat children hospitalized with bronchiolitis; however, the best practices for feeding during HFNC and the impact of feeding on time to discharge and adverse events are unknown. The study objective was to assess whether feeding exposure during HFNC was associated with time to discharge or feeding-related adverse events. This retrospective cohort study included inpatients aged 1-24 months receiving HFNC for bronchiolitis at an academic children’s hospital from January 1, 2015 to March 1, 2017. Feeding exposures during HFNC were categorized as fed or not fed. Among fed children, we further evaluated mixed (oral and tube) or exclusive oral feeding. The primary outcome was time to discharge after HFNC cessation. Secondary outcomes were aspiration, intubation after HFNC, and seven-day readmission. Of 123 children treated with HFNC, 45 (37 %) were never fed. A total of 78 children (63%) were fed; 50 (41%) were exclusively orally fed and 28 (23 %) had mixed feeding. Median (interquartile range) time to discharge after HFNC was 29.5 hours (23.5-47.9) and 39.8 hours (26.4-61.5) hours in the fed and not fed groups, respectively. In adjusted models, time to discharge was shorter with any feeding (hazard ratio [HR] 2.17; 95% CI: 1.34-3.50) and with exclusive oral feeding (HR 2.13; 95% CI: 1.31-3.45) compared with no feeding. Time to discharge from HFNC initiation was shorter for exclusive oral feeding versus not feeding (propensity weighted HR 1.97 [95% CI: 1.13-3.43]). Adverse events (one intubation, one aspiration pneumonia, one readmission) occurred in both groups. Assessment of feeding exposure did not account for quantity and duration. Children fed while receiving HFNC for bronchiolitis may have shorter time to discharge than those not fed. Feeding-related adverse events were rare regardless of the feeding method. Controlled prospective studies addressing residual confounding are needed to justify a change in the current practice.

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Effect of a scaled-up neonatal resuscitation quality improvement package on intrapartum-related mortality in Nepal: A stepped-wedge cluster randomized controlled trial

By Ashish KC ,Uwe Ewald, Omkar Basnet, Abhishek Gurung, Sushil Nath Pyakuryal, Bijay Kumar Jha, Anna Bergström, Leif Eriksson, Prajwal Paudel, Sushil Karki, Sunil Gajurel, Olivia Brunell, Johan Wrammert, Helena Litorp, Mats Målqvist. Published in PLOS One. September 9, 2019.   

 

Improving quality of intrapartum care will reduce intrapartum stillbirth and neonatal mortality, especially in resource-poor settings. Basic neonatal resuscitation can reduce intrapartum stillbirth and early neonatal mortality, if delivered in a high-quality health system, but there is a dearth of evidence on how to scale up such evidence-based interventions. We evaluated the scaling up of a quality improvement (QI) package for neonatal resuscitation on intrapartum-related mortality (intrapartum stillbirth and first day mortality) at hospitals in Nepal. We conducted a stepped-wedge cluster randomized controlled trial in 12 hospitals over a period of 18 months from April 14, 2017, to October 17, 2018. The hospitals were assigned to one of four wedges through random allocation. The QI package was implemented in a stepped-wedge manner with a delay of three months for each step. The QI package included improving hospital leadership on intrapartum care, building health workers’ competency on neonatal resuscitation, and continuous facilitated QI processes in clinical units. An independent data collection system was set up at each hospital to gather data on mortality through patient case note review and demographic characteristics of women using semi-structured exit interviews. The generalized linear mixed model (GLMM) and multivariate logistic regression were used for analyses. During this study period, a total of 89,014 women–infant pairs were enrolled. The mean age of the mother in the study period was 24.0 ± 4.3 years, with 54.9% from disadvantaged ethnic groups and 4.0% of them illiterate. Of the total birth cohort, 54.4% were boys, 16.7% had gestational age less than 37 weeks, and 17.1% had birth weight less than 2,500 grams. The incidence of intrapartum-related mortality was 11.0 per 1,000 births during the control period and 8.0 per 1,000 births during the intervention period (adjusted odds ratio [aOR], 0.79; 95% CI, 0.69–0.92; p = 0.002; intra-cluster correlation coefficient [ICC], 0.0286). The incidence of early neonatal mortality was 12.7 per 1,000 live births during the control period and 10.1 per 1,000 live births during the intervention period (aOR, 0.89; 95% CI, 0.78–1.02; p = 0.09; ICC, 0.1538). The use of bag-and-mask ventilation for babies with low Apgar score (<7 at 1 minute) increased from 3.2% in the control period to 4.0% in the intervention period (aOR, 1.52; 95% CI, 1.32–1.77, p = 0.003). There were two major limitations to the study; although a large sample of women–infant pairs were enrolled in the study, the clustering reduced the power of the study. Secondly, the study was not sufficiently powered to detect reduction in early neonatal mortality with the number of clusters provided. These results suggest scaled-up implementation of a QI package for neonatal resuscitation can reduce intrapartum-related mortality and improve clinical care. The QI intervention package is likely to be effective in similar settings. More implementation research is required to assess the sustainability of QI interventions and quality of care.

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Physiologically driven, altitude-adaptive model for the interpretation of pediatric oxygen saturation at altitudes above 2,000 m a.s.l.

By Laura Tüshaus, Monica Moreo, Jia Zhang, Stella Maria Hartinger, Daniel Mäusezahl, and Walter Karlen. Published in The Journal of Applied Physiology. September 1, 2019.  

Measuring peripheral oxygen saturation (SpO2) with pulse oximeters at the point of care is widely established. However, since SpO2 is dependent on ambient atmospheric pressure, the distribution of SpO2 values in populations living above 2000 m a.s.l. is largely unknown. Here, we propose and evaluate a computer model to predict SpO2 values for pediatric permanent residents living between 0 and 4,000 m a.s.l. Based on a sensitivity analysis of oxygen transport parameters, we created an altitude-adaptive SpO2 model that takes physiological adaptation of permanent residents into account. From this model, we derived an altitude-adaptive abnormal SpO2 threshold using patient parameters from literature. We compared the obtained model and threshold against a previously proposed threshold derived statistically from data and two empirical data sets independently recorded from Peruvian children living at altitudes up to 4,100 m a.s.l. Our model followed the trends of empirical data, with the empirical data having a narrower healthy SpO2 range below 2,000 m a.s.l. but the medians never differed more than 2.3% across all altitudes. Our threshold estimated abnormal SpO2 in only 17 out of 5,981 (0.3%) healthy recordings, whereas the statistical threshold returned 95 (1.6%) recordings outside the healthy range. The strength of our parametrized model is that it is rooted in physiology-derived equations and enables customization. Furthermore, as it provides a reference SpO2, it could assist practitioners in interpreting SpO2 values for diagnosis, prognosis, and oxygen administration at higher altitudes.

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Acute Oxygen Therapy on Hospital Wards in Low Middle-Income Country: Experience from a Referral Centre in Ilorin, Nigeria.

By Desalu OO, Oyedepo OO, Ojuawo OB, Ibraheem M, Aladesanmi AO, Suleiman ZA, Opeyemi CM, Adesina KT, Sanya EO, Salami AK. Published in West African Journal of Medicine. August 1, 2019.   

 

Oxygen is like any other medication that can cause severe consequences if administered inappropriately.To audit the pattern of acute oxygen therapy on regular hospital wards of a referral centre in Ilorin, Nigeria. We reviewed 150 patients that received or had a prescription for acute oxygen therapy in three months and extracted relevant information using a proforma. About one-third of the patients (30%) were >65 years of age and the male to female ratio was 1:1. The commonest indication and medical condition for acute oxygen administration were hypoxemia (70.7%) and pneumonia (26.0%), respectively. Pneumonia accounted for most (41.2 %) of the oxygen therapy in childhood. The majority of patients (88.0%) had written order for oxygen prescription, 40.7% had a prescription to target oxygen saturation and only 31.3% achieved their target saturation. Oxygen prescription was adequate (documentation of delivery device, flow rate of oxygen, and target oxygen saturations) in 40.7% of patients. The assessment, monitoring and titration of oxygen therapy were adequate in 92.7%, 65.3% and 28 % of patients respectively. Overall mortality was 27.3% in patients receiving acute oxygen supplementation. Eleven patients had unstable COPD, and 63.6 %, 54.5 % and 45.6 % of them had adequate oxygen prescription, monitoring and titration respectively. The challenges to oxygen use were faulty delivery devices, emptied oxygen cylinders, inability to routinely do arterial blood gas analysis and lack of hospital oxygen protocol. The current practice of acute oxygen therapy is not satisfactory and interventions are advocated to improve the healthcare providers' administration of oxygen.

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