Prematurity and Respiratory Outcomes Program (PROP) (PROP)
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| ClinicalTrials.gov Identifier: NCT01435187 |
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Recruitment Status :
Completed
First Posted : September 16, 2011
Last Update Posted : November 7, 2016
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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 or disease |
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| Prematurity Respiratory Disease |
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 continuous positive airway pressure (CPAP or BiPAP) of any duration 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.
During hospitalization, all centers will obtain samples of tracheal aspirate, urine and saliva (for DNA extraction) from enrolled infants. At 36 weeks PMA, infants will have respiratory assessments dependent upon their respiratory status: i) respiratory inductive plethysmography (RIP) assesses alterations in tidal breathing resulting from reduced lung compliance and airway obstruction, ii) and a room air challenge (RAC).
| Study Type : | Observational |
| Actual Enrollment : | 835 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Prematurity and Respiratory Outcomes Program (PROP) Core Database Protocol |
| Study Start Date : | August 2011 |
| Actual Primary Completion Date : | April 2015 |
| Actual Study Completion Date : | March 2016 |
| Group/Cohort |
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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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- Respiratory morbidity [ Time Frame: 1 year (corrected age) ]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
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| Ages Eligible for Study: | up to 7 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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:
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01435187
| United States, California | |
| Alta Bates Summit Medical Center | |
| Oakland, California, United States, 94609 | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94143 | |
| United States, Indiana | |
| Indiana University Health/Riley Hospital for Children | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Missouri | |
| Washington Universitiy | |
| St Louis, Missouri, United States, 63130 | |
| United States, New York | |
| University of Buffalo | |
| Buffalo, New York, United States, 14260 | |
| University of Rochester | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Cincinnati University Hospital | |
| Cincinnati, Ohio, United States, 45219 | |
| Good Samaritan Hospital | |
| Cincinnati, Ohio, United States, 45220 | |
| Cincinnati Children's Hospital | |
| Cincinnati, Ohio, United States, 45229 | |
| United States, Tennessee | |
| Jackson-Madison County General Hospital | |
| Jackson, Tennessee, United States, 38301 | |
| Monroe Carell Jr Children's Hospital at Vanderbilt | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| University of Texas, Houston | |
| Houston, Texas, United States, 77030 | |
| 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 |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01435187 |
| Other Study ID Numbers: |
813839 U01HL101794-02 ( U.S. NIH Grant/Contract ) |
| First Posted: | September 16, 2011 Key Record Dates |
| Last Update Posted: | November 7, 2016 |
| Last Verified: | November 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
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Respiration Disorders Premature Birth Respiratory Tract Diseases |
Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications |