NCT01435187|CompletedDMC
Prematurity and Respiratory Outcomes Program (PROP)
PROP
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PROP
Sponsor study identifier
Secondary identifiers
observational
835
1 country
13
Study Start
August 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2015
Actual (reported)Study Completion
March 2016
Actual (reported)In survivors of extreme prematurity to 36 weeks Post Menstrual Age (PMA), specific biologic, physiologic and clinical data obtained during the initial hospitalization will predict respiratory morbidity as defined by respiratory health care utilization and respiratory symptoms, between discharge and 1 year corrected age. This protocol describes a collaboratively developed multicenter study of very preterm infants from birth through the time of discharge from the Neonatal Intensive Care Unit (NICU) and up to 1 year of age, corrected for the degree of prematurity.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2011
Date type not reportedThis date has not been verified as actual or estimated.
September 14, 2011
Actual (reported)September 16, 2011
Actual (reported)April 2015
Actual (reported)March 2016
Actual (reported)Respiratory morbidity
The primary goal of the PROP studies (single center and multicenter protocols) is to identify biomarkers (biochemical, physiological and genetic) and clinical variables that are associated with and thus potentially predictive of pulmonary status in preterm infants up to 1 year corrected age.
1 year (corrected age)
A standardized method of performing infant PFTs using the raised volume rapid thoracoabdominal compression (RVRTC) technique will be used. This test will be performed on infants at one year (corrected age). The target sample size of 180 studies will represent the largest number of RVRTC PFTs in the preterm population and will enhance study of the relationship between lung function at 1 year of age and clinical and biologic factors associated with respiratory disease. Although the primary PFT measures will be derived from RVRTC, V'maxFRC, respiratory system compliance (Crs) and resistance (Rrs) will also be measured because these can be easily obtained. Crs and Rrs will be obtained using the single breath occlusion method.
Infants admitted to the Neonatal Intensive Care Unit who are \< 29 weeks gestational age
Alta Bates Summit Medical Center
Oakland, California, 94609, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Indiana University Health/Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Washington Universitiy
St Louis, Missouri, 63130, United States
University of Buffalo
Buffalo, New York, 14260, United States
University of Rochester
Rochester, New York, 14642, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Maitre NL, Ballard RA, Ellenberg JH, Davis SD, Greenberg JM, Hamvas A, Pryhuber GS; Prematurity and Respiratory Outcomes Program. Respiratory consequences of prematurity: evolution of a diagnosis and development of a comprehensive approach. J Perinatol. 2015 May;35(5):313-321. doi: 10.1038/jp.2015.19. Epub 2015 Mar 26.
Pryhuber GS, Maitre NL, Ballard RA, Cifelli D, Davis SD, Ellenberg JH, Greenberg JM, Kemp J, Mariani TJ, Panitch H, Ren C, Shaw P, Taussig LM, Hamvas A; Prematurity and Respiratory Outcomes Program Investigators. Prematurity and respiratory outcomes program (PROP): study protocol of a prospective multicenter study of respiratory outcomes of preterm infants in the United States. BMC Pediatr. 2015 Apr 10;15:37. doi: 10.1186/s12887-015-0346-3.
Saliva for DNA, Urine and Tracheal Aspirate
Barbara K Schmidt, MD
University of Pennsylvania
Jonas H Ellenberg, PhD
University of Pennsylvania
Gloria S Pryhuber, MD
University of Rochester
Alan H Jobe, MD, PhD
Cincinnati Childrens Hospital
835 participants (actual enrollment reported by the registry).
First Submitted
September 14, 2011
First Posted
September 16, 2011
Study Start
August 2011
Date type not reportedThis date has not been verified as actual or estimated.
Electrocardiography Versus Pulse Oximetry for Newborn Heart Rate Determination
Contact the study team to confirm eligibility.
Cincinnati University Hospital
Cincinnati, Ohio, 45219, United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
Jackson-Madison County General Hospital
Jackson, Tennessee, 38301, United States
Monroe Carell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232, United States
University of Texas, Houston
Houston, Texas, 77030, United States
Poindexter BB, Feng R, Schmidt B, Aschner JL, Ballard RA, Hamvas A, Reynolds AM, Shaw PA, Jobe AH; Prematurity and Respiratory Outcomes Program. Comparisons and Limitations of Current Definitions of Bronchopulmonary Dysplasia for the Prematurity and Respiratory Outcomes Program. Ann Am Thorac Soc. 2015 Dec;12(12):1822-30. doi: 10.1513/AnnalsATS.201504-218OC.
Dylag AM, Kopin HG, O'Reilly MA, Wang H, Davis SD, Ren CL, Pryhuber GS. Early Neonatal Oxygen Exposure Predicts Pulmonary Morbidity and Functional Deficits at 1 Year. J Pediatr. 2020 Aug;223:20-28.e2. doi: 10.1016/j.jpeds.2020.04.042.
Voynow JA, Fisher K, Sunday ME, Cotten CM, Hamvas A, Hendricks-Munoz KD, Poindexter BB, Pryhuber GS, Ren CL, Ryan RM, Sharp JK, Young SP, Zhang H, Greenberg RG, Herring AH, Davis SD. Urine gastrin-releasing peptide in the first week correlates with bronchopulmonary dysplasia and post-prematurity respiratory disease. Pediatr Pulmonol. 2020 Apr;55(4):899-908. doi: 10.1002/ppul.24665. Epub 2020 Jan 29.
Ren CL, Feng R, Davis SD, Eichenwald E, Jobe A, Moore PE, Panitch HB, Sharp JK, Kisling J, Clem C, Kemp JS. Tidal Breathing Measurements at Discharge and Clinical Outcomes in Extremely Low Gestational Age Neonates. Ann Am Thorac Soc. 2018 Nov;15(11):1311-1319. doi: 10.1513/AnnalsATS.201802-112OC.
Blaisdell CJ, Troendle J, Zajicek A; Prematurity and Respiratory Outcomes Program. Acute Responses to Diuretic Therapy in Extremely Low Gestational Age Newborns: Results from the Prematurity and Respiratory Outcomes Program Cohort Study. J Pediatr. 2018 Jun;197:42-47.e1. doi: 10.1016/j.jpeds.2018.01.066. Epub 2018 Mar 26.
Keller RL, Feng R, DeMauro SB, Ferkol T, Hardie W, Rogers EE, Stevens TP, Voynow JA, Bellamy SL, Shaw PA, Moore PE; Prematurity and Respiratory Outcomes Program. Bronchopulmonary Dysplasia and Perinatal Characteristics Predict 1-Year Respiratory Outcomes in Newborns Born at Extremely Low Gestational Age: A Prospective Cohort Study. J Pediatr. 2017 Aug;187:89-97.e3. doi: 10.1016/j.jpeds.2017.04.026. Epub 2017 May 17.
Aaron Hamvas, MD
Washington University School of Medicine / St. Louis Children's Hospital
Judy Aschner, MD
Vanderbilt University School of Medicine
Roberta L Keller, MD
University of California San Francisco/Benioff Children's Hospital
Judith Voynow, MD
Duke University
Stephanie D Davis, MD
Indiana University/Riley Hospital for Children
Primary Completion
April 2015
Actual (reported)Study Completion
March 2016
Actual (reported)Last Updated
November 7, 2016
Record last verified: 2016-11
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