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Infant specific-IgE, rhinovirus-C bronchiolitis, and incident asthma in
MARC-35 (MARC-35 42-Month Exam)

Summary of Research Protocol

Principal Investigator:
Carlos A. Camargo, MD, DrPH, Massachusetts General Hospital, Boston, MA

Co-investigators:
Ari R. Cohen, MD, Massachusetts General Hospital, Boston, MA
Janice A. Espinola, MPH, Massachusetts General Hospital, Boston, MA
Kohei Hasegawa, MD, MPH, Massachusetts General Hospital, Boston, MA

External Co-investigators:
Anne Beasley, MD, Phoenix Children's Hospital, Phoenix, AZ
Juan Celedon, MD, DrPH, Children's Hospital of Pittsburgh, Pittsburgh, PA 
Michael R. Gomez, MD, MS-HCA, The Children's Hospital at Saint Francis, Tulsa, OK 
Sujit Iyer, MD, Dell Children's Medical Center of Central Texas, Austin, TX 
Federico Laham, MD, MS, Arnold Palmer Hospital, Orlando, FL 
Charles G. Macias, MD, Baylor College of Medicine, Houston, TX
Jonathan M. Mansbach, MD, MPH, Children’s Hospital Boston, Boston, MA
Pedro A. Piedra, MD, Baylor College of Medicine, Houston, TX
Henry T. Puls, MD, The Children’s Mercy Hospital & Clinics, Kansas City, MO
Michelle D. Stevenson, MD, MS, University of Louisville, Louisville, KY
Richard T. Strait, MD, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH 
Stephen J. Teach, MD, MPH, Children’s National Medical Center, Washington, DC 
Vincent Wang, MD, MHA, Children's Hospital of Los Angeles, Los Angeles, CA
Ilana Waynik, MD, Connecticut Children's Medical Center, Hartford, CT 

Consultants:
Michelle B. Dunn, MD, Children’s Hospital of Philadelphia, Philadelphia, PA 
Thida Ong, MD, Seattle Children's Hospital, Seattle, WA 
Amy Thompson, MD, Alfred I. duPont Hospital for Children, Wilmington, DE 

Coordinating Center Staff

Steering Committee

Scientific Advisory Board

Funding Source: National Institutes of Health (R01AI114552)

Purpose: (1) To determine the relations of infant specific IgE type and longitudinal pattern to the risk of incident asthma at age 5 years; (2) To examine the association of  rhinovirus type bronchiolitis with risk of incident asthma at age 5 years; (3) To test for an interaction between infant sIgE and RV-C bronchiolitis with regard to the risk of incident asthma at age 5 years.

Rationale: Bronchiolitis is the #1 cause of infant hospitalization in the USA. Small cohort studies (n<210) suggest that 40-50% of hospitalized infants with bronchiolitis will develop childhood asthma. Unfortunately, it remains unclear which infants will develop asthma and this knowledge gap has hindered primary prevention efforts. The 35th Multicenter Airway Research Collaboration (MARC-35) study is a NIH-funded, 17-center prospective cohort study that completed enrollment of 940 hospitalized infants with bronchiolitis (80% ward, 20% intensive care unit) in April 2014. In this diverse U.S. cohort (~52% African-American or Hispanic), site investigators have collected nasopharyngeal and blood samples ; extensive interview and survey data; and medical records from primary care, emergency department, and inpatient settings. Preliminary data (n=745) already show a strong interaction between infant specific-IgE and rhinovirus (not yet typed) and two available outcomes: risk of recurrent wheeze by age 12 months and use of inhaled corticosteroids by age 18 months (both Pinteraction<0.01). The study advances research on the primary prevention of asthma, and matches well with the 2009 NIH strategic plan for pediatric respiratory research.

Procedure: The study will include participants previously enrolled in MARC-35.  We will examine IgE sensitization longitudinally by testing serum specific IgE at age 42 months (3.5 years), rhinovirus typing by partial sequencing for rhinovirus samples from the index hospitalization, and continued follow-up with biannual telephone calls and annual chart reviews through age 5 years. The study involves an in-person exam around age 3 years. The brief visit includes an informed consent, a simple skin (eczema) and quality of life questionnaire for applicable participants, nose (polyp), and lung exam, a blood draw (≥5mL-15mL) and a nasal swab with associated questionnaire. The study will be coordinated by the EMNet Coordinating Center (Boston, MA). Approximately 60% of these exams will occur at enrolling sites’ clinical research centers, many of which are part of the Clinical and Translational Science Award (CTSA) consortium. However, based on our experience with the MARC-35 cohort, we know that up to 20% of participants will have moved since their enrollment – and an additional 21% may not have access to a local clinical research center. These children (between 20 to 41%) will either go to the office of a local clinician for their exam or have a qualified mobile service designated by the EMNet Coordinating Center perform these assessments at their respective homes. Local clinicians will be identified and recruited in the geographic areas needed.

 

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