Trial record 11 of 486 for:    Open Studies | "Infant, Premature"

Functional and Lymphocytic Markers of Respiratory Morbidity in Hyperoxic Preemies

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2011 by University of Rochester
Sponsor:
Collaborators:
University at Buffalo
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT01607216
First received: March 14, 2012
Last updated: January 2, 2014
Last verified: October 2011
  Purpose

This is an observational study that proposes to collect clinical, physiological, cellular and molecular information in an attempt to identify a set of factors that may predict the risk for persistent lung disease in babies born prematurely.


Condition
Prematurity
Symptomatic Respiratory Disease
Bronchopulmonary Dysplasia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prematurity and Respiratory Outcome Program: Single Center Study of Functional and Lymphocytic Markers of Respiratory Morbidity in Hyperoxic Preemies

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Symptomatic Respiratory Disease (SRD) [ Time Frame: Assessed every three months until 1 year corrected gestational 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. 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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 210
Study Start Date: August 2011
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Premature Infant
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.

Detailed Description:

Approximately 550,000 babies born prematurely each year in the United States suffer from birth at a time in development when the respiratory tract and immune system would normally be protected and maintained in a naïve state. This project is a component of the NIH Prematurity and Respiratory Outcomes Program (PROP) whose goals are the identification of disease mechanisms and biomarkers to stratify premature infants, at the time of discharge, for their risk of subsequent pulmonary morbidity. This Clinical Research Center (CRC) project will investigate prematurity-dependent alterations in cellular innate and adaptive immune systems resulting in increased susceptibility to respiratory infections and environmental irritants, and leading to respiratory morbidity in the first year of life. Prior studies have established developmental (maturity) and disease-related changes in circulating and pulmonary lymphocyte populations but a comprehensive assessment of their relationship to disease risk/outcome has not been undertaken. We hypothesize that cellular and molecular immuno-maturity is altered due to intrinsic and extrinsic factors presented by premature birth in such a way as to reduce resistance to viral infections and to promote cytotoxic damage to the lung. We will evaluate immunologic maturity by comprehensively phenotyping lymphocyte populations in peripheral blood sampled at premature delivery, at the time of discharge from the hospital and at twelve months corrected age. The lymphocytic phenotype will be analyzed particularly in the context of gestational age and maternal-fetal stressors capable of modulating oxidative stress (oxygen exposure, infection and environmental tobacco smoke exposure). Additionally, we will assess changes in the molecular phenotype of isolated CD8 lymphocytes, a cell type preferentially recruited to the lungs of premature infants and capable of contributing to disease pathogenesis, by genome-wide expression profiling, in order to uncover novel disease pathways and define a gene expression signature associated with disease risk. Finally, we propose to build a statistical model, using cellular and molecular phenotypes and additional clinical variables, for stratifying risk of lung morbidity within the first year of life.

  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

Eligible subjects are limited to patients born at the Golisano Children's Hospital at the University of Rochester Medical Center and at Women's and Children's Hospital, University at Buffalo. All admissions to the participating Neonatal Intensive Care Units will be screened for eligibility.

Criteria

Inclusion Criteria:

  1. Premature infants born at gestational age 24 0/7 to 35 6/7 week and admitted to the Neonatal Intensive Care Unit or normal newborn nursery at URMC or UB
  2. Healthy term infants 37 0/7 to 41 6/7 recruited from the birthing centers or Ob/Gyn floors (3-1200 at URMC) prior to discharge
  3. Infants who are less than or equal to 7 days old

Exclusion Criteria:

  1. The infant is not considered to be viable (therapies limited due to futility decision made by clinical care team)
  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 as determined by the site investigators dependent on the distance of the infant's residence from the follow-up center and/or family plans to move out of the region
  6. Family does not speak or understand English
  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: NCT01607216

Contacts
Contact: Gloria Pryhuber, MD 585-273-4120 gloria_pryhuber@urmc.rochester.edu
Contact: Elizabeth Werner, MPH 585-273-2322 elizabeth_werner@urmc.rochester.edu

Locations
United States, New York
Women and Children's Hospital of Buffalo Recruiting
Buffalo, New York, United States, 14222
Contact: Anne Marie Reynolds, MD, MPH    716-878-7673    areynolds@upa.chob.edu   
Principal Investigator: Anne Marie Reynolds, MD, MPH         
Sub-Investigator: Jack Sharp, MD         
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Gloria Pryhuber, MD    585-273-4120    gloria_pryhuber@urmc.rochester.edu   
Contact: Thomas Mariani, PhD    585-276-4616    tom_mariani@urmc.rochester.edu   
Principal Investigator: Gloria Pryhuber, MD         
Principal Investigator: Thomas Mariani, PhD         
Sub-Investigator: Carl D'Angio, MD         
Sub-Investigator: Timothy Stevens, MD, MPH         
Sub-Investigator: Clement Ren, MD         
Sponsors and Collaborators
University of Rochester
University at Buffalo
Investigators
Principal Investigator: Gloria Pryhuber, MD University of Rochester
Principal Investigator: Rita Ryan, MD University at Buffalo
Principal Investigator: Thomas Mariani, PhD University of Rochester
  More Information

No publications provided

Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT01607216     History of Changes
Other Study ID Numbers: 37933, U01HL101813
Study First Received: March 14, 2012
Last Updated: January 2, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Rochester:
Prematurity
Respiratory Illness
Lung Function
Lung Disease

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Respiration Disorders
Respiratory Tract Diseases
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on August 28, 2014