Prematurity and Respiratory Outcomes Program (PROP)
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Purpose
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.
| Condition |
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Prematurity Respiratory Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prematurity and Respiratory Outcomes Program (PROP) Core Database Protocol |
- Respiratory morbidity [ Time Frame: 1 year (corrected age) ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples With DNA
Saliva for DNA, Urine and Tracheal Aspirate
| Estimated Enrollment: | 750 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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Infant Pulmonary Function Testing (iPFT)
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.
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Detailed Description:
The primary goal of the PROP studies 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. An objective and validated measure of pulmonary outcome at 1 year does not currently exist. Some promising measures are in development but not yet ready for use in a multi-center large clinical study.
Moreover, the burden of chronic respiratory illness on the infants and their families is of utmost importance. A composite primary outcome of morbidity that is based on serial parental reports of respiratory symptoms, medications, hospitalizations and dependence on technology during the first year of life has been developed.
Data collection for the outcome assessment will be based on interviews conducted with the infant's main caregiver at 3, 6, 9 and 12 months corrected age. The time frame for data collection is based on questions "since last contact." Numerous epidemiological studies of asthma have used parental or self report of symptoms, physician-diagnosed asthma and allergies, or the use of medications (which may abrogate symptoms) as critical outcomes.
Survey items selected for the determination of the primary outcome will be focused on the following four domains, with any positive response to any element identifying morbidity:
- Respiratory medications: inhaled bronchodilators, inhaled steroids, systemic steroids, methylxanthines, diuretics, pulmonary vasodilators
- Hospitalizations for cardiopulmonary causes: any hospitalization regardless of duration
- Symptoms: any wheeze, cough without cold
- Home technology dependence: use of home oxygen, ventilator or CPAP/BiPAP of any durations since last contact
The primary outcome will be dichotomous, and defined as "No substantial post-prematurity respiratory disease" or "Post-prematurity respiratory disease." To be classified as having post-prematurity respiratory disease, infants must have a positive response in at least 1 of 4 morbidity domains during at least 2 separate parental interviews. Quarterly data collection up to 1 year corrected age will allow us to identify phenotypes based on the trajectory of post-prematurity respiratory disease and how these different trajectories predict later lung function and the diagnosis of asthma, if we continue to follow this cohort of children.
Eligibility| Ages Eligible for Study: | up to 7 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Infants admitted to the Neonatal Intensive Care Unit who are < 29 weeks gestational age
Inclusion Criteria:
- Infants who are less than or equal to 7 days old
- Gestational Age (GA) between 23 weeks and 0/7 days and 28 weeks and 6/7 days
Exclusion Criteria:
Infants who meet any of the following conditions will be excluded from the PROP cohort:
- The infant is not considered to be viable (decision made not to provide life-saving therapies)
- Congenital heart disease (not including PDA and hemodynamically insignificant VSD or ASD)
- Structural abnormalities of the upper airway, lungs or chest wall
- Other congenital malformations or syndromes that adversely affect life expectancy or cardio-pulmonary development
- Family is unlikely to be available for long-term follow-up
Contacts and Locations| Contact: Denise Cifelli, MS | cifelli@mail.med.upenn.edu |
| United States, California | |
| Alta Bates Summit Medical Center | Recruiting |
| Oakland, California, United States, 94609 | |
| Contact: David Durand, MD Ddurand@mail.cho.org | |
| Principal Investigator: David Durand, MD | |
| University of California, San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Roberta L. Keller, MD kellerr@peds.ucsf.edu | |
| Principal Investigator: Roberta L. Keller, MD | |
| Principal Investigator: Philip L. Ballard, MD, PhD | |
| United States, Indiana | |
| Indiana University Health/Riley Hospital for Children | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Principal Investigator: Stephanie D Davis, MD | |
| Sub-Investigator: Brenda Poindexter, MD | |
| United States, Missouri | |
| Washington Universitiy | Recruiting |
| St Louis, Missouri, United States, 63130 | |
| Principal Investigator: Aaron Hamvas, MD | |
| Principal Investigator: Thomas Ferkol, MD | |
| United States, New York | |
| University of Buffalo | Recruiting |
| Buffalo, New York, United States, 14260 | |
| Contact: Anne Marie Reynolds, MD areynolds@upa.chob.edu | |
| Principal Investigator: Gloria S Pryhuber, MD | |
| Principal Investigator: Thomas Mariani, PhD | |
| Principal Investigator: Rita M Ryan, MD | |
| University of Rochester | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Gloria S. Pryhuber, MD Gloria_pryhuber@urmc.rochester.edu | |
| Principal Investigator: Gloria S Pryhuber, MD | |
| Principal Investigator: Thomas Mariani, PhD | |
| Principal Investigator: Rita M Ryan, MD | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: Judith Voynow, MD | |
| Sub-Investigator: Michael Cotten, MD | |
| United States, Ohio | |
| Cincinnati University Hospital | Recruiting |
| Cincinnati, Ohio, United States, 45219 | |
| Principal Investigator: Alan H Jobe, MD, PhD | |
| Principal Investigator: Claire Chougnet, PhD | |
| Cincinnati Children's Hospital | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| Principal Investigator: Claire Chougnet, PhD | |
| Principal Investigator: Alan H Jobe, MD, PhD | |
| Good Samaritan Hospital | Recruiting |
| Cincinnati, Ohio, United States, 45220 | |
| Principal Investigator: Alan H Jobe, MD, PhD | |
| Principal Investigator: Claire Chougnet, PhD | |
| United States, Tennessee | |
| Jackson-Madison County General Hospital | Recruiting |
| Jackson, Tennessee, United States, 38301 | |
| Contact: Scott O. Guthrie, MD scott.o.guthrie@vanderbilt.edu | |
| Principal Investigator: Scott O Guthrie, MD | |
| Monroe Carell Jr Children's Hospital at Vanderbilt | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Judy Aschner, MD judy.aschner@vanderbilt.edu | |
| Principal Investigator: Judy Aschner, MD | |
| Principal Investigator: Paul Moore, MD | |
| United States, Texas | |
| University of Texas, Houston | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Eric C. Eichenwald, MD eric.c.eichenwald@uth.tmc.edu | |
| Principal Investigator: Eric Eichenwald, MD | |
| Principal Investigator: | Barbara K Schmidt, MD | University of Pennsylvania |
| Principal Investigator: | Jonas H Ellenberg, PhD | University of Pennsylvania |
| Principal Investigator: | Gloria S Pryhuber, MD | University of Rochester |
| Principal Investigator: | Alan H Jobe, MD, PhD | Cincinnati Childrens Hospital |
| Principal Investigator: | Aaron Hamvas, MD | Washington University School of Medicine / St. Louis Children's Hospital |
| Principal Investigator: | Judy Aschner, MD | Vanderbilt University School of Medicine |
| Principal Investigator: | Roberta L Keller, MD | University of California San Francisco/Benioff Children's Hospital |
| Principal Investigator: | Judith Voynow, MD | Duke University |
| Principal Investigator: | Stephanie D Davis, MD | Indiana University/Riley Hospital for Children |
More Information
No publications provided
| Responsible Party: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01435187 History of Changes |
| Other Study ID Numbers: | 813839, UO1-HL-101794-02 |
| Study First Received: | September 14, 2011 |
| Last Updated: | March 14, 2012 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Respiration Disorders Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013