NeOProM: Neonatal Oxygenation Prospective Meta-analysis Collaboration study protocol

Background: The appropriate level of oxygenation for extremely preterm neonates ( 90%) have been reported to have greater rates of morbidity including retinopathy of prematurity and chronic lung disease. In order to answer this clinical dilemma reliably, large scale trial evidence is needed.Methods/Design: To detect a small but important 4% increase in death or severe disability in survivors, over 5000 neonates would need to be recruited. As extreme prematurity affects 1% of births, such a project undertaken by one trial group would be prohibitively lengthy and expensive. Hence, the Neonatal Oxygenation Prospective Meta-analysis (NeOProM) Collaboration has been formed. A prospective meta-analysis (PMA) is one where studies are identified, evaluated, and determined to be eligible before the results of any included studies are known or published, thereby avoiding some of the potential biases inherent in standard, retrospective meta-analyses. This methodology provides the same strengths as a single large-scale multicentre randomised study whilst allowing greater pragmatic flexibility. The NeOProM Collaboration protocol (NCT01124331) has been agreed prior to the results of individual trials being available. This includes pre-specifying the hypotheses, inclusion criteria and outcome measures to be used. Each trial will first publish their respective results as they become available and the combined meta-analytic results, using individual patient data, will be published when all trials are complete. The primary outcome to be assessed is a composite outcome of death or major disability at 18 months - 2 years corrected age. Secondary outcomes include several measures of neonatal morbidity. The size of the combined dataset will allow the effect of the interventions to be explored more reliably with respect to pre-specified patient- and intervention-level characteristics.Discussion: Results should be available by 2014

Risk factors for sudden infant death syndrome in a developing country Fatores de risco para síndrome da morte súbita do lactente em um país em desenvolvimento

OBJECTIVE: To analyze whether previously identified risk factors for sudden death syndrome have a significant impact in a developing country. METHODS: Retrospective longitudinal case-control study carried out in Porto Alegre, Southern Brazil. Cases (N=39) were infants born between 1996 and 2000 who died suddenly and unexpectedly at home during sleep and were diagnosed with sudden death syndrome. Controls (N=117) were infants matched by age and sex who died in hospitals due to other conditions. Data were collected from postmortem examination records and questionnaires answers. A conditional logistic model was used to identify factors associated with the outcome. RESULTS: Mean age at death of cases was 3.2 months. The frequencies of infants regarding gestational age, breastfeeding and regular medical visits were similar in both groups. Sleeping position for most cases and controls was the lateral one. Supine sleeping position was found for few infants in both groups. Maternal variables, age below 20 years (OR=2, 95% CI: 1.1; 5.1) and smoking of more than 10 cigarettes per day during pregnancy (OR=3, 95% CI: 1.3; 6.4), significantly increased the risk for the syndrome. Socioeconomic characteristics were similar in both groups and did not affect risk. CONCLUSIONS: Infant-maternal and socioeconomic profiles of cases in a developing country closely resembled the profile described in the literature, and risk factors were similar as well. However, individual characteristics were identified as risks in the population studied, such as smoking during pregnancy and maternal age below 20 years.<br>OBJETIVO: Analisar se fatores de risco previamente identificados para a síndrome da morte súbita do lactente têm impacto significativo em um país em desenvolvimento. MÉTODOS: Estudo retrospectivo, longitudinal, de caso-controle pareado realizado em Porto Alegre, RS. Os casos (N=39) foram lactentes nascidos entre 1996 e 2000 que morreram subitamente e inesperadamente em casa, ao dormir, com diagnóstico final da síndrome; o grupo controle (N=117) foi composto de lactentes pareados por idade e sexo que morreram em hospitais, por outra doença. Os dados foram coletados de registros médicos postmortem e respostas a questionários. Utilizou-se modelo de regressão logística para identificar os fatores associados ao desfecho. RESULTADOS: A idade média dos casos no momento da morte dos lactentes foi de 3,2 meses. As freqüências de idade gestacional, amamentação e visitas regulares a unidades básicas de saúde foram similares nos dois grupos. A posição de dormir mais comum nos casos e controles foi a lateral. A posição supina foi encontrada em alguns lactentes em ambos grupos. As variáveis maternas idade inferior a 20 anos (OR=2, IC 95%:1,1;5,1) e consumo de mais de 10 cigarros/dia durante a gravidez (OR=3, IC 95%: 1,3;6,4) aumentaram significativamente o risco para a síndrome. As características socioeconômicas foram similares entre os grupos e não afetaram o risco. CONCLUSÕES: Os perfis lactente-materno e os fatores de risco foram similares aos encontrados em outros países. Todavia, foram identificadas características individuais quanto aos riscos de fumar durante a gravidez e da idade materna inferior a 20 anos