Abstract
BackgroundWith 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/DesignThe 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.DiscussionPROP incorporates aspects of NICU care to develop objective biomarkers and outcome measures of respiratory morbidity in the <29 week gestation population beyond just the NICU hospitalization, thereby leading to novel understanding of the nature and natural history of neonatal lung disease and of potential mechanistic and therapeutic targets in at-risk subjects.Trial registrationClinical Trials.gov NCT01435187.Electronic supplementary materialThe online version of this article (doi:10.1186/s12887-015-0346-3) contains supplementary material, which is available to authorized users.
Highlights
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
The risks of developing respiratory disease in preterm infants are inversely related to their gestational age at birth (GA), with a diagnosis of bronchopulmonary dysplasia further increasing this risk
Summary and progress through enrollment Enrollment began August 3, 2011 and concluded November 1, 2013 (Figure 4); the follow-up to one year corrected age is expected to continue through mid-2015
Summary
Short- and long-term respiratory complications of premature birth are increasing, adding significantly to financial and health burdens in the United States. In recognition of the gaps in definitional, operational and mechanistic understanding, the Prematurity and Respiratory Outcomes Program (PROP) was created to characterize and develop a means of predicting clinically meaningful and persistent pulmonary disease of prematurity, in the context of current neonatal intensive care practices [1]. It is a multi-disciplinary, six-center, 13-site organization (Table 1) fostering the collaboration of neonatologists, pulmonologists, and basic scientists working to identify biomarkers of one-year respiratory morbidity and mortality in a cohort of more than 750 extremely preterm infants. The data gathered through this project will be used to investigate mechanisms contributing to respiratory disease of the preterm newborns and to provide high-resolution phenotyping of disease severity for use in clinical applications and future trials
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