Immunologic Features of Respiratory Failure in Pediatric Hematopoietic Cell Transplantation (HCT) Recipients and Pediatric Oncology Patients

  • STATUS
    Recruiting
  • End date
    May 30, 2025
  • participants needed
    40
  • sponsor
    St. Jude Children's Research Hospital
Updated on 5 April 2022
mechanical ventilation
acute respiratory failure
pulmonary disease
assisted ventilation

Summary

This study is being done because researchers want to learn more about genes that control the immune response in the participant's lungs and blood when the participant have lung disease leading to respiratory failure.

Primary Objective

To evaluate the feasibility of performing single cell gene expression analyses on tracheal aspirates from immunocompromised pediatric patients with immune compromising conditions, including HCT recipients.

Secondary Objectives

  • To assess whether cell composition and activation states in longitudinally obtained tracheal aspirate and blood samples are able to distinguish unique immunopathology for each of the early post-HCT lung diseases.
  • To assess whether cell composition and activation states in longitudinally obtained tracheal aspirate and blood samples are different between two immunodeficient patient populations (alloHCT vs non alloHCT) with lung disease and respiratory failure.
  • To test the hypothesis that allogeneic T cell responses are implicated in the pathogenesis of early post-HCT lung diseases.

Exploratory Objectives

To correlate immune cell signaling in the lower respiratory tract and blood of patients with early post-HCT lung diseases with the presence or absence of pathogenic microbes at each site.

To explore HLA testing in Tracheal Aspirates in samples where enough cells are present.

Description

This study involves a Tracheal aspirate, Bronchoalveolar lavage (BAL), and blood samples. The tracheal aspirates and blood samples will be obtained within 24 hours of intubation, then twice more every 3 -4 days, and then once a week until the patient is extubated. If the primary treatment team performs bronchoscopy with BAL, then an aliquot of residual BAL fluid will be obtained.

Details
Condition Respiratory Failure, Respiratory Disease
Clinical Study IdentifierNCT04355780
SponsorSt. Jude Children's Research Hospital
Last Modified on5 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant is age 0 to 21 years old
Participant has acute respiratory failure due to primary pulmonary disease and is expected to receive invasive mechanical ventilation for more than 48 hours

Exclusion Criteria

The primary etiology of respiratory failure is not related to primary pulmonary disease
Aspiration is present
The participant has a tracheostomy
If the patient has undergone HCT, they are more than 100 days removed from HCT
Has a diagnosis of severe combined immunodeficiency syndrome (SCIDS)
The primary on-service team feels obtaining a study sample would be unsafe for any reason
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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