Functional and Lymphocytic Markers of Respiratory Morbidity in Hyperoxic Preemies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01607216|
Recruitment Status : Completed
First Posted : May 30, 2012
Last Update Posted : January 13, 2020
|Condition or disease|
|Prematurity Symptomatic Respiratory Disease Bronchopulmonary Dysplasia|
|Study Type :||Observational|
|Actual Enrollment :||277 participants|
|Official Title:||Prematurity and Respiratory Outcome Program: Single Center Study of Functional and Lymphocytic Markers of Respiratory Morbidity in Hyperoxic Preemies|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Infants born 23 0/7 weeks gestation to 35 6/7 weeks gestation.
Healthy Full Term Infants
Infants born between 37 0/7 weeks gestation to 41 6/7 weeks gestation.
- Symptomatic Respiratory Disease (SRD) [ Time Frame: Assessed every three months until 1 year corrected gestational 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. We propose a composite primary outcome of SRD that is based on serial parental reports of respiratory symptoms, medications, hospitalizations and dependence on technology during the first year of life.
- Assessment of T lymphocyte numbers, subsets (CD4, CD8) and functional phenotype determined by flow cytometry. [ Time Frame: Measured and compared at birth, at term corrected gestational age and at 1 year corrected gestational age ]Assessment of T lymphocyte numbers, subsets (CD4, CD8) and functional phenotype including characteristics of effector and memory function, and intracellular cytokine production in response to in vitro T cell receptor nonspecific and specific stimulation
- Measure of severity of lung disease at 40 +/- 5 weeks corrected gestational age [ Time Frame: From birth at premature gestational age to at 40 +/- 5 weeks corrected gestational age ]Severity of lung disease will be assessed by length of time on mechanical ventilation, length of time on oxygen, oxygen requirement at 36 weeks corrected gestational age, need for pulmonary medications at determined at hospital discharge, or at 40 +/- 5 weeks corrected gestational age.
- Statistical correlation of CD4 and CD8 lymphocyte function with severity and persistence of lung disease. [ Time Frame: At at 40 +/- 5 weeks corrected gestational age and at one year of age ]The severity of lung disease prior to first hospital discharge and the persistence and severity of SRD in the first year of life will be compared with the T cell lymphocyte phenotypes at birth, at hospital discharge and at one year of life. Specifically, at minimum, the ability of T lymphocytes at rest and after stimulation to produce interferon gamma at the test time points will be compared with the history of lung disease. The intent is to identify biomarkers and to suggest immune-mediated mechanisms for lung disease in preterm infants
- Gene expression analysis of CD8 cells collected by FACS from preterm infants nearing discharge [ Time Frame: At 40 +/- 5 weeks corrected gestational age ]Patterns of gene expression identified in isolated and sorted CD8 T cells from preterm infants just prior to discharge from the neonatal intensive care unit will be identified and compared to the severity and persistence of symptomatic respiratory disease (SRD) over the first year of life.
Biospecimen Retention: Samples With DNA
Several types of biospecimens are to be collected:
Cord Blood Tracheal Aspirates Urine Stool Saliva Blood
DNA collection is optional.
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): NCT01607216
|United States, New York|
|Women and Children's Hospital of Buffalo|
|Buffalo, New York, United States, 14222|
|University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Gloria Pryhuber, MD||University of Rochester|
|Principal Investigator:||Rita Ryan, MD||University at Buffalo|
|Principal Investigator:||Thomas Mariani, PhD||University of Rochester|