Oxygen systems to improve clinical care and outcomes for children and neonates: A stepped-wedge cluster-randomised trial in Nigeria.

BACKGROUND: Improving oxygen systems may improve clinical outcomes for hospitalised children with acute lower respiratory infection (ALRI). This paper reports the effects of an improved oxygen system on mortality and clinical practices in 12 general, paediatric, and maternity hospitals in southwest Nigeria. METHODS AND FINDINGS: We conducted an unblinded stepped-wedge cluster-randomised trial comparing three study periods: baseline (usual care), pulse oximetry introduction, and stepped introduction of a multifaceted oxygen system. We collected data from clinical records of all admitted neonates (<28 days old) and children (28 days to 14 years old). Primary analysis compared the full oxygen system period to the pulse oximetry period and evaluated odds of death for children, children with ALRI, neonates, and preterm neonates using mixed-effects logistic regression. Secondary analyses included the baseline period (enabling evaluation of pulse oximetry introduction) and evaluated mortality and practice outcomes on additional subgroups. Three hospitals received the oxygen system intervention at 4-month intervals. Primary analysis included 7,716 neonates and 17,143 children admitted during the 2-year stepped crossover period (November 2015 to October 2017). Compared to the pulse oximetry period, the full oxygen system had no association with death for children (adjusted odds ratio [aOR] 1.06; 95% confidence interval [CI] 0.77-1.46; p = 0.721) or children with ALRI (aOR 1.09; 95% CI 0.50-2.41; p = 0.824) and was associated with an increased risk of death for neonates overall (aOR 1.45; 95% CI 1.04-2.00; p = 0.026) but not preterm/low-birth-weight neonates (aOR 1.30; 95% CI 0.76-2.23; p = 0.366). Secondary analyses suggested that the introduction of pulse oximetry improved oxygen practices prior to implementation of the full oxygen system and was associated with lower odds of death for children with ALRI (aOR 0.33; 95% CI 0.12-0.92; p = 0.035) but not for children, preterm neonates, or neonates overall (aOR 0.97, 95% CI 0.60-1.58, p = 0.913; aOR 1.12, 95% CI 0.56-2.26, p = 0.762; aOR 0.90, 95% CI 0.57-1.43, p = 0.651). Limitations of our study are a lower-than-anticipated power to detect change in mortality outcomes (low event rates, low participant numbers, high intracluster correlation) and major contextual changes related to the 2016-2017 Nigerian economic recession that influenced care-seeking and hospital function during the study period, potentially confounding mortality outcomes. CONCLUSIONS: We observed no mortality benefit for children and a possible higher risk of neonatal death following the introduction of a multifaceted oxygen system compared to introducing pulse oximetry alone. Where some oxygen is available, pulse oximetry may improve oxygen usage and clinical outcomes for children with ALRI. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12617000341325.

Mortality for Critical Congenital Heart Diseases and Associated Risk Factors in Newborns. A Cohort Study / Mortalidade para Cardiopatias Congênitas e Fatores de Risco Associados em Recém-Nascidos. Um Estudo de Coorte

Abstract Background: Congenital heart diseases are the most common type of congenital defects, and account for more deaths in the first year of life than any other condition, when infectious etiologies are ruled out. Objectives: To evaluate survival, and to identify risk factors in deaths in newborns with critical and/or complex congenital heart disease in the neonatal period. Methods: A cohort study, nested to a randomized case-control, was performed, considering the Confidence Interval of 95% (95% CI) and significance level of 5%, paired by gender of the newborn and maternal age. Case-finding, interviews, medical record analysis, clinical evaluation of pulse oximetry (heart test) and Doppler echocardiogram were performed, as well as survival analysis, and identification of death-related risk factors. Results: The risk factors found were newborns younger than 37 weeks (Relative Risk - RR: 2.89; 95% CI [1.49-5.56]; p = 0.0015), weight of less than 2,500 grams (RR: 2.33 [; 95% CI 1.26-4.29]; p = 0.0068), occurrence of twinning (RR: 11.96 [95% CI 1.43-99.85]; p = 0.022) and presence of comorbidity (RR: 2.27 [95% CI 1.58-3.26]; p < 0.0001). The incidence rate of mortality from congenital heart disease was 81 cases per 100,000 live births. The lethality attributed to critical congenital heart diseases was 64.7%, with proportional mortality of 12.0%. The survival rate at 28 days of life decreased by almost 70% in newborns with congenital heart disease. The main cause of death was cardiogenic shock. Conclusion: Preterm infants with low birth weight and comorbidities presented a higher risk of mortality related to congenital heart diseases. This cohort was extinguished very quickly, signaling the need for greater investment in assistance technology in populations with this profile.

Resumo Fundamento: As cardiopatias congênitas configuram o tipo mais comum de defeitos congênitos, sendo responsáveis por mais mortes no primeiro ano de vida do que em qualquer outra condição, quando etiologias infecciosas são excluídas. Objetivo: Avaliar a sobrevida e identificar os fatores de risco nos óbitos em recém-nascidos com cardiopatia congênita crítica e/ou complexa no período neonatal. Métodos: Realizou-se um estudo de coorte, aninhado a um caso-controle aleatorizado, considerando Intervalo de Confiança de 95% (IC95%) e nível de significância de 5%, pareado por sexo do recém-nascido e idade materna. Foram feitas buscas ativas de casos, entrevistas, análise de prontuário, avaliação clínica da oximetria de pulso (teste do coraçãozinho) e do ecoDopplercardiograma, bem como análise de sobrevida e identificação dos fatores de risco relacionados ao óbito. Resultados: Os fatores de risco encontrados foram recém-nascidos com menos de 37 semanas (Risco Relativo − RR: 2,89; IC95% 1,49-5,56; p = 0,0015), peso inferior a 2.500 g (RR: 2,33; IC95% 1,26-4,29; p = 0,0068), ocorrência de gemelaridade (RR: 11,96; IC95% 1,43-99,85; p = 0,022) e presença de comorbidade (RR: 2,27; IC95% 1,58-3,26; p < 0,0001). A taxa de incidência de mortalidade por cardiopatias congênitas foi de 81 casos por 100 mil nascidos vivos. A letalidade atribuída às cardiopatias congênitas críticas foi de 64,7%, com mortalidade proporcional de 12,0%. A taxa de sobrevida aos 28 dias de vida diminuiu em quase 70% nos recém-nascidos com cardiopatias congênitas. A principal causa de óbito foi o choque cardiogênico. Conclusão: Recém-nascidos prematuros, com baixo peso e presença de comorbidades apresentaram maior risco de mortalidade relacionada às cardiopatias congênitas. Esta coorte se extinguiu muito rapidamente, sinalizando para a necessidade de maior investimento em tecnologia assistencial em populações com este perfil.

Mortality for Critical Congenital Heart Diseases and Associated Risk Factors in Newborns. A Cohort Study.

BACKGROUND: Congenital heart diseases are the most common type of congenital defects, and account for more deaths in the first year of life than any other condition, when infectious etiologies are ruled out. OBJECTIVES: To evaluate survival, and to identify risk factors in deaths in newborns with critical and/or complex congenital heart disease in the neonatal period. METHODS: A cohort study, nested to a randomized case-control, was performed, considering the Confidence Interval of 95% (95% CI) and significance level of 5%, paired by gender of the newborn and maternal age. Case-finding, interviews, medical record analysis, clinical evaluation of pulse oximetry (heart test) and Doppler echocardiogram were performed, as well as survival analysis, and identification of death-related risk factors. RESULTS: The risk factors found were newborns younger than 37 weeks (Relative Risk - RR: 2.89; 95% CI [1.49-5.56]; p = 0.0015), weight of less than 2,500 grams (RR: 2.33 [; 95% CI 1.26-4.29]; p = 0.0068), occurrence of twinning (RR: 11.96 [95% CI 1.43-99.85]; p = 0.022) and presence of comorbidity (RR: 2.27 [95% CI 1.58-3.26]; p < 0.0001). The incidence rate of mortality from congenital heart disease was 81 cases per 100,000 live births. The lethality attributed to critical congenital heart diseases was 64.7%, with proportional mortality of 12.0%. The survival rate at 28 days of life decreased by almost 70% in newborns with congenital heart disease. The main cause of death was cardiogenic shock. CONCLUSION: Preterm infants with low birth weight and comorbidities presented a higher risk of mortality related to congenital heart diseases. This cohort was extinguished very quickly, signaling the need for greater investment in assistance technology in populations with this profile.

Does pulse oximeter use impact health outcomes? A systematic review.

OBJECTIVE: Do newborns, children and adolescents up to 19 years have lower mortality rates, lower morbidity and shorter length of stay in health facilities where pulse oximeters are used to inform diagnosis and treatment (excluding surgical care) compared with health facilities where pulse oximeters are not used? DESIGN: Studies were obtained for this systematic literature review by systematically searching the Database of Abstracts of Reviews of Effects, Cochrane, Medion, PubMed, Web of Science, Embase, Global Health, CINAHL, WHO Global Health Library, international health organisation and NGO websites, and study references. PATIENTS: Children 0-19 years presenting for the first time to hospitals, emergency departments or primary care facilities. INTERVENTIONS: Included studies compared outcomes where pulse oximeters were used for diagnosis and/or management, with outcomes where pulse oximeters were not used. MAIN OUTCOME MEASURES: mortality, morbidity, length of stay, and treatment and management changes. RESULTS: The evidence is low quality and hypoxaemia definitions varied across studies, but the evidence suggests pulse oximeter use with children can reduce mortality rates (when combined with improved oxygen administration) and length of emergency department stay, increase admission of children with previously unrecognised hypoxaemia, and change physicians' decisions on illness severity, diagnosis and treatment. Pulse oximeter use generally increased resource utilisation. CONCLUSIONS: As international organisations are investing in programmes to increase pulse oximeter use in low-income settings, more research is needed on the optimal use of pulse oximeters (eg, appropriate oxygen saturation thresholds), and how pulse oximeter use affects referral and admission rates, length of stay, resource utilisation and health outcomes.

Continuously recorded oxygen saturation and heart rate during prehospital transport outperform initial measurement in prediction of mortality after trauma.

INTRODUCTION: Available trauma scoring systems that predict need for higher echelons of care require data not available in the field. We hypothesized that analysis of continuous vital sign data in comparison to trauma registry data predicts mortality early in trauma patient management. METHODS: A real-time vital signs wave form and data capture system collected trauma patient data during prehospital management from Propaq 206E physiologic monitors. Analysis using statistical and mathematical software calculated receiver operator characteristic curves to evaluate the sensitivity and specificity of continuous vital sign waveforms in predicting mortality. The area under the curve (AUC) was calculated to determine nonsurvival by a particular vital sign (oxygen saturation [SpO2], heart rate, and systolic blood pressure) from these data, compared with a single value in the trauma registry, and to standard trauma scoring systems. RESULTS: The average transport time from field to hospital for all patients was 25 minutes. Eight of 120 patients (7%) died; 5 of 8 patients (62%) died within the first 24 hours. Receiver operator characteristic analysis of mean SpO2 <90% versus mortality yielded an AUC of 0.76 (p = 0.005) with a sensitivity of 62% and specificity of 86% The initial SpO2 <90% measurement from the trauma registry yielded an AUC of 0.59. Preadmission Glasgow Coma Scale score yielded an AUC of 0.74 (p = 0.009). Injury Severity Score and Trauma-Injury Severity Score produced AUCs of 0.91 and 0.96, respectively. Revised Trauma Score gave an AUC of 0.73, no different from automated predictions of mortality from SpO2. CONCLUSION: Injury Severity Score and Trauma-Injury Severity Score are predictive of mortality but rely on the inclusion of intra-abdominal and intrathoracic diagnostic data that are not readily available during field assessment. Automated vital signs data collection and analysis from a single noninvasive device with decision support has the potential to alleviate the dual burdens of patient triage and documentation required of the prehospital provider.