Prematurity and Respiratory Outcomes Program (PROP)

Completed

Conditions studied: Prematurity, Respiratory Disease

In brief

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.

Key facts

Study ID

NCT01435187

Run by

University of Pennsylvania

People needed

835

Starts

2011-08-01

Expected to finish

2016-03-01

Last updated by the study team

2016-11-07

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.