Prematurity and respiratory outcomes program (PROP): study protocol of a prospective multicenter study of respiratory outcomes of preterm infants in the United States
Prematurity and respiratory outcomes program (PROP): study protocol of a prospective multicenter study of respiratory outcomes of preterm infants in the United States
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DOI：
10.1186/s12887-015-0346-3
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发表时间：
2015-04-10
期刊：
影响因子：
2.4
通讯作者：
Hamvas, Aaron
中科院分区：
文献类型：
--
作者：
Pryhuber, Gloria S.;Maitre, Nathalie L.;Hamvas, Aaron
背景：随着存活率的提高，早产的短期和长期呼吸道并发症正在增加，大大增加了美国的经济和健康负担。作为回应，2010年5月，美国国立卫生研究院(NIH)和国家心肺血液研究所(NHLBI)资助了一项为期5年、耗资1,850万美元的研究计划，以最终改善管理早产儿和低出生体重儿呼吸道并发症的策略。使用协作、多学科结构，由此产生的早产儿和呼吸结局计划(PROP)试图了解与未来呼吸道疾病风险相关的因素。方法/设计：PROP是由六个临床中心(在13个地点合并三级新生儿重症监护病房[NICU])和一个与NHLBI合作的数据协调中心进行的观察性前瞻性队列研究。每个临床中心都为这项研究提供研究对象，招募胎龄230/7到28 6/7周的婴儿，预期目标是在月经后36周时存活750人。此外，每个中心都为该计划带来了特定的科学重点领域。主要的研究假设是，在极端早产儿幸存者中，特定的生物、生理和临床数据可以预测出院到1岁矫正年龄之间的呼吸道发病率。分析统计方法包括基于模型和非基于模型的分析、描述性分析和广义线性混合模型。讨论：PROP结合了NICU护理的各个方面，以开发客观的生物标记物和结果衡量呼吸道疾病的发病率
Background: With improved survival rates, short-and long-term respiratory complications of premature birth are increasing, adding significantly to financial and health burdens in the United States. In response, in May 2010, the National Institutes of Health (NIH) and the National Heart, Lung, and Blood Institute (NHLBI) funded a 5-year $18.5 million research initiative to ultimately improve strategies for managing the respiratory complications of preterm and low birth weight infants. Using a collaborative, multi-disciplinary structure, the resulting Prematurity and Respiratory Outcomes Program (PROP) seeks to understand factors that correlate with future risk for respiratory morbidity.Methods/Design: The PROP is an observational prospective cohort study performed by a consortium of six clinical centers (incorporating tertiary neonatal intensive care units [NICU] at 13 sites) and a data-coordinating center working in collaboration with the NHLBI. Each clinical center contributes subjects to the study, enrolling infants with gestational ages 23 0/7 to 28 6/7 weeks with an anticipated target of 750 survivors at 36 weeks post-menstrual age. In addition, each center brings specific areas of scientific focus to the Program. The primary study hypothesis is that in survivors of extreme prematurity specific biologic, physiologic and clinical data predicts respiratory morbidity between discharge and 1 year corrected age. Analytic statistical methodology includes model-based and non-model-based analyses, descriptive analyses and generalized linear mixed models.Discussion: PROP incorporates aspects of NICU care to develop objective biomarkers and outcome measures of respiratory morbidity in the