Functional and Lymphocytic Markers of Respiratory Morbidity in Hyperoxic Preemies

NCT01607216 | Completed DMC

• 2 other identifiers: 37933U01HL101813
• Study Type: observational
• Target: 277
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prematurity; Symptomatic Respiratory Disease; Bronchopulmonary Dysplasia

Keywords

Prematurity; Respiratory Illness; Lung Function; Lung Disease

Outcome Measures

Primary Outcomes (1)

• Symptomatic Respiratory Disease (SRD)

  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.

  Assessed every three months until 1 year corrected gestational age

Secondary Outcomes (4)

• Assessment of T lymphocyte numbers, subsets (CD4, CD8) and functional phenotype determined by flow cytometry.

  Measured and compared at birth, at term corrected gestational age and at 1 year corrected gestational age

• Measure of severity of lung disease at 40 +/- 5 weeks corrected gestational age

  From birth at premature gestational age to at 40 +/- 5 weeks corrected gestational age

• Statistical correlation of CD4 and CD8 lymphocyte function with severity and persistence of lung disease.

  At at 40 +/- 5 weeks corrected gestational age and at one year of age

• Gene expression analysis of CD8 cells collected by FACS from preterm infants nearing discharge

  At 40 +/- 5 weeks corrected gestational age

Study Arms (2)

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.

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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
• 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
• Infants who are less than or equal to 7 days old

You may not qualify if:

• The infant is not considered to be viable (therapies limited due to futility decision made by clinical care team)
• 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 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
• Family does not speak or understand English

Sponsors & Collaborators

• University of Rochester: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University at Buffalo: collaborator

Study Sites (2)

Women and Children's Hospital of Buffalo

Buffalo, New York, 14222, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (6)

• 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):313-321. doi: 10.1038/jp.2015.19. Epub 2015 Mar 26.

  PMID: 25811285 BACKGROUND

• 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.

  PMID: 25886363 BACKGROUND

• Scheible KM, Emo J, Yang H, Holden-Wiltse J, Straw A, Huyck H, Misra S, Topham DJ, Ryan RM, Reynolds AM, Mariani TJ, Pryhuber GS. Developmentally determined reduction in CD31 during gestation is associated with CD8+ T cell effector differentiation in preterm infants. Clin Immunol. 2015 Dec;161(2):65-74. doi: 10.1016/j.clim.2015.07.003. Epub 2015 Jul 29.

  PMID: 26232733 BACKGROUND

• Misra R, Shah S, Fowell D, Wang H, Scheible K, Misra S, Huyck H, Wyman C, Ryan RM, Reynolds AM, Mariani T, Katzman PJ, Pryhuber GS. Preterm cord blood CD4(+) T cells exhibit increased IL-6 production in chorioamnionitis and decreased CD4(+) T cells in bronchopulmonary dysplasia. Hum Immunol. 2015 May;76(5):329-338. doi: 10.1016/j.humimm.2015.03.007. Epub 2015 Mar 20.

  PMID: 25797206 RESULT

• Grier A, Qiu X, Bandyopadhyay S, Holden-Wiltse J, Kessler HA, Gill AL, Hamilton B, Huyck H, Misra S, Mariani TJ, Ryan RM, Scholer L, Scheible KM, Lee YH, Caserta MT, Pryhuber GS, Gill SR. Impact of prematurity and nutrition on the developing gut microbiome and preterm infant growth. Microbiome. 2017 Dec 11;5(1):158. doi: 10.1186/s40168-017-0377-0.

  PMID: 29228972 RESULT

• Hoover J, Wambach J, Vachharajani A, Warner B, Carroll JL, Kemp JS. Postmenstrual age at discharge in premature infants with and without ventilatory pattern instability. J Perinatol. 2020 Jan;40(1):157-162. doi: 10.1038/s41372-019-0530-7. Epub 2019 Oct 14.

  PMID: 31611617 DERIVED

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.

MeSH Terms

Conditions

Premature Birth; Bronchopulmonary Dysplasia; Lung Diseases

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ventilator-Induced Lung Injury; Lung Injury; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Gloria Pryhuber, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Rita Ryan, MD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

• Thomas Mariani, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: May 30, 2012
• Study Start: August 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

US (2)