Clinical and Immunological Evaluation of Children With Allergies
Condition: Hypersensitivity, Immediate
MeSH terms: Hypersensitivity; Hypersensitivity, Immediate
Study type: Observational

Summary: 
      This study will evaluate children with allergies and collect medical data and biological
      specimens from them periodically to learn more about the diseases and gain information that
      may be useful in developing new treatments.

      Patients 6 months to 18 years of age with a possible diagnosis of asthma, rhinitis,
      anaphylaxis, hives, atopic dermatitis, food allergy, stinging insect allergy, and other
      allergic and inflammatory diseases may be eligible for this study. Biological parents of
      patients may also be enrolled to provide a blood sample for genetic studies.

      Participants undergo tests appropriate for the diagnosis and management of their allergy.
      They include the tests outlined below and, when necessary, additional blood tests, tissue
      biopsies (surgical removal of a small piece of tissue for microscopic examination), computed
      tomography (CT) or magnetic resonance imaging (MRI).

        -  Pulmonary function test: This test evaluates lung function. The patient blows hard into
           a tube attached to a machine to measure the airflow from the lungs. At home, the patient
           uses a small plastic device called a peak flow meter to measure lung function. Patients
           whose lung function measures less than 80 percent the value predicted for his or her age
           may be given the medicine albuterol to see if lung function improves.

        -  Skin prick testing: Drops of up to 55 different allergens (foreign substances, such as
           pollen and certain foods or medicines that cause reactions like sneezing, hives, eczema,
           and others) are placed on the back or arm. The skin under the allergen is then scratched
           with a pointed tool. If the person is allergic, the skin around the scratch develops a
           small area of itching, redness, or swelling that goes away after 30 to 60 minutes.

        -  Acoustic rhinometry: To learn the effect of allergies on the size of the nasal cavity,
           the nasal canal size is measured by placing a small round probe on the nostril. The
           device sends out and receives a sound wave signal from which the size of the nasal canal
           is calculated, recorded and stored graphically on a computer screen. The procedure is
           repeated three times with each nostril.

        -  Computerized assessment of learning and mood: Patients who are age 10 or older may take
           this computer test to find out if allergies affect learning and mood. The test measures
           the child's ability to understand directions, solve problems, and remember things. It
           also includes questions about how the child feels in general.

        -  Behavioral assessment system for children: Patients who are age 8 or older may take this
           true/false questionnaire to assess mood.

        -  Blood may be drawn for the following purposes: in lieu of skin prick testing to
           determine sensitivity to allergens; to look for reasons for the severity or cause of an
           allergy; for research studies on the immune system, including markers of allergy; for
           genetic tests to determine inherited factors that increase the risk of developing
           allergies.

      Patients are scheduled for follow-up visits based on their diagnosis and severity of illness.
      Most patients return for within one month of their first study visit and then, in general,
      once a month when allergies are severe, and every few months when they are more stable.
      Visits include an updated history and physical examination, blood tests, and possibly some of
      the tests described above. Patients may also have intradermal skin testing, in which
      allergens that are used for skin prick testing are injected into the forearms or upper arms
      just below the surface of the skin.

      Patients who test positive to allergens may be offered standard treatment with allergy shots.
    

Detailed description: 
      Atopic disorders, including but not limited to asthma, rhinitis, anaphylaxis, urticaria,
      atopic dermatitis, food allergy, and stinging insect allergy are exceedingly common in the
      pediatric population. The impact that these disorders have on health, educational and social
      activities and costs of medical care are profound and widespread. In order to understand
      disease and improve therapy, the study of pediatric allergy is justifiably an important
      health priority and the goal of this protocol. This purpose will be fostered through the
      following objectives: 1) To gather a database of clinical and immunological data and to
      better clinically and immunologically characterize disease onset, progression and remittance
      of these disorders; 2) to foster collaborative studies in pediatric allergic disease with
      other institutions and 3) to provide a cohort of pediatric patients for residents in the NIH
      Clinical Center/NIAID Allergy and Immunology training program. Up to 500 new patients will be
      enrolled to attain these goals. Patients will undergo screening history, physical
      examination, and clinical laboratory evaluation according to the standard of practice in the
      community. Although imaging studies and tissue biopsies will be performed only when
      clinically indicated, blood samples for cellular and biochemical studies may be collected for
      research purposes. Treatment plans will be individualized for each patient and the number and
      length of additional visits and diagnostic evaluations will vary accordingly. Standard
      immunotherapy for allergic disease may be offered. Through the assessment, analysis, and
      treatment of a large cohort of patients, we will better understand disease manifestations,
      trends, outcomes, and mechanisms of pediatric allergy and lay the groundwork for discovery of
      new therapeutic modalities.
    

Keywords: Pediatric; Atopic; Asthma; Rhinitis; Outpatient; Allergy; Pediatric Allergy; Food Allergy; Stinging Insect Allergy; Atopic Dermatitis; Insect Sting