Prematurity and Respiratory Outcomes Program (PROP)

Prematurity Clinical Trial

— PROP  

Official title:

Prematurity and Respiratory Outcomes Program (PROP) Core Database Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01435187
• Other study ID #: 813839
• Secondary ID: U01HL101794-02
• Status: Completed
• Phase: N/A
• First received: September 14, 2011
• Last updated: November 4, 2016
• Start date: August 2011
• Est. completion date: March 2016

Study information

• Verified date: November 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 835
• Est. completion date: March 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Premature Birth
• Prematurity
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Locations

Country	Name	City	State
United States	University of Buffalo	Buffalo	New York
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	Cincinnati University Hospital	Cincinnati	Ohio
United States	Good Samaritan Hospital	Cincinnati	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Texas, Houston	Houston	Texas
United States	Indiana University Health/Riley Hospital for Children	Indianapolis	Indiana
United States	Jackson-Madison County General Hospital	Jackson	Tennessee
United States	Monroe Carell Jr Children's Hospital at Vanderbilt	Nashville	Tennessee
United States	Alta Bates Summit Medical Center	Oakland	California
United States	University of Rochester	Rochester	New York
United States	University of California, San Francisco	San Francisco	California
United States	Washington Universitiy	St Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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):313-21. doi: 10.1038/jp.2015.19. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No