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Prematurity and Respiratory Outcomes Program (PROP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01435187
First received: September 14, 2011
Last updated: January 7, 2014
Last verified: April 2013
  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
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

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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
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.

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:

  1. Respiratory medications: inhaled bronchodilators, inhaled steroids, systemic steroids, methylxanthines, diuretics, pulmonary vasodilators
  2. Hospitalizations for cardiopulmonary causes: any hospitalization regardless of duration
  3. Symptoms: any wheeze, cough without cold
  4. 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).

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Infants admitted to the Neonatal Intensive Care Unit who are < 29 weeks gestational age

Criteria

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:

    1. The infant is not considered to be viable (decision made not to provide life-saving therapies)
    2. Congenital heart disease (not including PDA and hemodynamically insignificant VSD or ASD)
    3. Structural abnormalities of the upper airway, lungs or chest wall
    4. Other congenital malformations or syndromes that adversely affect life expectancy or cardio-pulmonary development
    5. Family is unlikely to be available for long-term follow-up
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435187

Locations
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 Children's Hospital
Cincinnati, Ohio, United States, 45229
Cincinnati University Hospital
Cincinnati, Ohio, United States, 45219
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
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
Sponsors and Collaborators
University of Pennsylvania
Investigators
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: January 7, 2014
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 November 25, 2014