Airway Inflammatory Response During Illness in Children With Respiratory Failure
| Status: | Withdrawn |
|---|---|
| Conditions: | Hospital, Pulmonary, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | Any - 17 |
| Updated: | 11/16/2017 |
| Start Date: | July 2017 |
| End Date: | August 2019 |
Investigation of Airway Inflammatory Response During an Acute Respiratory Illness in Pediatric Patients With Respiratory Failure
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.
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.
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.
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.
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
We found this trial at
1
site
101 Manning Dr
Chapel Hill, North Carolina 27599
Chapel Hill, North Carolina 27599
(919) 966-4131
University of North Carolina Hospital at Chapel Hill The UNC Health Care System is a...
Click here to add this to my saved trials
