Airway Inflammatory Response During Illness in Children With Respiratory Failure

NCT02047877 | Withdrawn DMC

• 1 other identifier: 13-2784
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Respiratory Secretions; Tracheal Secretions; Bronchial Secretions; NonBronchoscopic BAL; Interleukin 10; Interleukin 12p70

Outcome Measures

Primary Outcomes (1)

• Mean log transformed IL-10:IL-12p70 ratio in tracheal secretion, bronchial secretion, and serum within 48-hours of mechanical ventilation

  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. Three time points were chosen to show consistency in ratio of IL-10 to IL-12p70 between TA and nb-BALF throughout the first week of endotracheal intubation. If a patient is extubated before day 7 all sample collection will stop. No samples will be obtained after 7 days of intubation as we are focusing on the acute phase of lung injury only. An ELISA assay is performed to measure the concentration of IL-10 and IL-12p70 for ratio comparison.

  Within 48 hours of mechanical ventilation

Secondary Outcomes (3)

• Blood oxygenation saturation and hemodynamic changes following non-bronchoscopic BAL

  Baseline through 1-hour post procedure

• Mean log transformed IL-10:IL-12p70 ratio in tracheal secretion, bronchial secretion, and serum between days 3-4

  Days 3 to 4 of mechanical ventilation

• Mean log transformed IL-10:IL-12p70 ratio in tracheal secretion, bronchial secretion, and serum between days 5-7

  Days 5 to 7 of mechanical ventilation

Other Outcomes (1)

• Fraction of screened patients enrolled, fraction of patients with complete sample collection, and fraction of patients with complete clinical data

  1-Year from Initial Enrollment

Study Arms (1)

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.

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Previously healthy patients presenting to UNC with respiratory failure presumptively caused by a primary lung infection will be screened. Only those patients intubated within 48-hours of potential enrollment and between the ages of ≥37 weeks gestation and 17 years will be considered. For purposes of this study, acute respiratory illness is defined as having upper respiratory infection symptoms and/or lower respiratory tract infection. Patient should have fever (\>38 oC) OR leukocytosis / leukopenia (\>10,000 or \<2,000) AND any of the following: tachypnea, hypoxia (saturation \<97%), cough, congestion, rhinorrhea, abnormal lung exam findings, or infiltrate on chest x-ray.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina Hospital at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Will bank all remaining serum, tracheal secretion, and bronchial secretion de-identified for purposes of future unknown scientific studies designed at examining respiratory secretions in this defined pediatric population.

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Daniel Lercher, MD

  University of North Carolina Hospital at Chapel Hill

  PRINCIPAL INVESTIGATOR

• Benny Joyner, MD, MPH

  University of North Carolina, Chapel Hill

  STUDY DIRECTOR

• Benny L Joyner, Jr., MD, MPH

  University of North Carolina, Chapel Hill

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2014
• First Posted: January 28, 2014
• Study Start: July 1, 2017
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: November 14, 2017

Record last verified: 2017-11

Locations

US (1)