Airway Inflammatory Response During Illness in Children With Respiratory Failure

NCT ID: NCT02047877

Last Updated: 2017-11-14

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-31
• Study Completion Date: 2019-08-31

Brief Summary

The purpose of this study has two major goals: 1) to measure the amount of two specific hormones interleukin (IL)-10 and interleukin (IL)-12p70 in mucous and blood; and 2) compare the hormone levels in two specific areas of the lung called the trachea (upper airway) and the bronchioles (lower airway). The hormones IL-10 and IL-12p70 are cytokines, special hormones cells use to communicate with each other during inflammation or infection. Cytokines can be measured in mucous and blood. The balance of one cytokine compared to another help doctors to understand how people respond differently to infection. Unfortunately, the amount of IL-10 and IL-12p70 is not known in children, especially children with a lung infection. In addition, we do not know if the balance of these cytokines differ in various regions of the lung. We believe the balance of IL-10 and IL-12p70 is similar whether measured in the upper or lower airways.

Detailed Description

This study is designed to measure the concentration and describe the distribution of cytokine IL-10 and IL-12p70 in a previously healthy pediatric population suffering direct lung injury by an infectious etiology, not yet described in the literature.

In addition, this study seeks to determine whether tracheal aspirates (TA) obtained in early acute respiratory failure can be substituted for distal airway aspirates, obtained by non-bronchoscopic broncho-alevolar lavage (nb-BAL), for the purposes of investigating markers of inflammation. We will compare the ratio of IL-10 to IL-12p70 at each time point measured in tracheal secretion, bronchial secretion, and blood to assess for sample equivalence.

Finally, this study will affirm the safety profile for repeated nb-BAL, establish a protocol for respiratory sample collection and storage for future larger scale studies, and generate feasibility data regarding consent rate, estimates of data completion, and fraction of missing data for us to determine whether a future study involving the ratio of IL-10 to IL-12p70 can be used as a predictor of acute respiratory distress syndrome (ARDS) in this population.

The data generated by this study regarding safety, comparison of nb-BAL and TA, and cytokine concentrations will be used as preliminary data informing the design of a larger multicenter study testing the hypothesis that IL-10 and IL-12p70 levels in airway secretions can predict risk for ARDS in this population. This may be approached via application to the Pediatric Acute Lung Injury and Sepsis (PALISI) clinical research network group.

Conditions

Acute Respiratory Failure; Acute Respiratory Infection; Acute Respiratory Distress Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Respiratory Illness

Previously healthy patients admitted with acute respiratory illness who are then intubated requiring mechanical ventilator support. Endotracheally intubated patients of age 37 weeks gestation through 17 years with an acute respiratory illness in the absence of existing cardiopulmonary disease, tracheostomy, or immunocompromised condition. Tracheal aspirates (TA), bronchial fluid (nb-BALF), and blood are collected within 48-hours following endotracheal intubation. All three samples are collected again at two additional time points following intubation: between days 3-4 and between days 5-7, so long as the patient remains endotracheally intubated.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Previously healthy
• Age 37 weeks gestation through 17 years
• Presumed respiratory infection
• Intubated <48 hours

Exclusion Criteria

• Trauma, Drowning, Pancreatitis, or Sepsis not originating from a pulmonary infection.
• Pre-existing chronic disease including:
• congenital heart disease or acquired cardiomyopathy
• pulmonary hypertension
• restrictive lung disease
• cystic fibrosis
• asthma controlled with chronically inhaled steroids
• Tracheostomy
• Immunocompromised including chronic steroid use within last month
• Oncological condition except conditions in active remission not requiring maintenance chemotherapy.
• Intubated patient with an endotracheal tube <3.5 mm
• Patients with persistent SpO2 <90% despite adequate ventilator support, or patients deemed too unstable to undergo mini-BAL by the clinical care team

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Lercher, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina Hospital at Chapel Hill

Benny Joyner, MD, MPH

Role: STUDY_DIRECTOR

University of North Carolina, Chapel Hill

Benny L Joyner, Jr., MD, MPH

Role: STUDY_CHAIR

University of North Carolina, Chapel Hill

Locations

University of North Carolina Hospital at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

13-2784

Identifier Type: -

Identifier Source: org_study_id