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Prematurity and Respiratory Outcomes Program (PROP)

NCT01435187 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 835

Last updated 2016-11-07

No results posted yet for this study

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.

Conditions

  • Prematurity
  • Respiratory Disease

Sponsors & Collaborators

Principal Investigators

  • Barbara K Schmidt, MD · University of Pennsylvania

  • Jonas H Ellenberg, PhD · University of Pennsylvania

  • Gloria S Pryhuber, MD · University of Rochester

  • Alan H Jobe, MD, PhD · Cincinnati Childrens Hospital

  • Aaron Hamvas, MD · Washington University School of Medicine / St. Louis Children's Hospital

  • Judy Aschner, MD · Vanderbilt University School of Medicine

  • Roberta L Keller, MD · University of California San Francisco/Benioff Children's Hospital

  • Judith Voynow, MD · Duke University

  • Stephanie D Davis, MD · Indiana University/Riley Hospital for Children

Eligibility

Min Age
1 Day
Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2015-04-30
Completion
2016-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01435187 on ClinicalTrials.gov