Status:
COMPLETED
Melbourne Infant Study - Bacille Calmette Guérin (BCG) for Allergy & Infection Reduction
Lead Sponsor:
Murdoch Childrens Research Institute
Collaborating Sponsors:
Royal Children's Hospital
Mercy Hospital for Women, Australia
Conditions:
Allergy
Eczema
Eligibility:
All Genders
Up to 10 years
Phase:
PHASE3
Brief Summary
1. To determine if BCG immunisation at birth, compared to no BCG immunisation, leads to a reduction in measures of allergy and infection in the first 12 months of life. 2. To evaluate the immunologica...
Detailed Description
There has been a dramatic rise in allergic diseases worldwide since the 1980s. Asthma rates increased first, followed by eczema, allergic rhinitis and, more recently, food allergy - especially in infa...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Less than 10 days old;
- English speaking mother;
- An informed consent form must be signed and dated by their parent(s) or legally acceptable representative after the nature of the study has been explained and prior to any study assessments/procedures;
- The infant's mother has screened negative for HIV during this pregnancy;
- Born no earlier than eight weeks before estimated date of delivery;
- Birth weight \>1500g.
- The legal guardian expects to be able to complete four online/phone questionnaires over the infant's first 12 months of life and for the infant to be available for skin prick testing at RCH between 12-16 months of age.
- Exclusion criteria:
- Any indication for BCG immunisation in the first 12 months of life including:
- likely travel to a high tuberculosis (TB) incidence country in the first year of life.
- Aboriginal and Torres Strait Islander babies living in parts of Australia where the incidence of TB is higher
- newborn babies, if either parent has leprosy or a family history of leprosy
- newborn in contact with a patient with TB.
- Known or suspected HIV infection
- Treatment with corticosteroids or other immunosuppressive therapy, including monoclonal antibodies against tumour necrosis factor-alpha (TNF-alpha) (e.g. infliximab, etanercept, adalimumab).
- Born to a mother treated with bDMARDS (e.g. TNF-alpha blocking monoclonal antibodies) in the 3rd trimester;
- Congenital cellular immunodeficiencies including specific deficiencies of the interferon gamma pathway;
- Malignancies involving bone marrow or lymphoid systems;
- Serious underlying illness including severe malnutrition;
- Medically unstable;
- Generalised septic skin disease and skin conditions such as eczema, dermatitis and psoriasis;
- Significant febrile illness;
- Mother immunosuppressed;
- Family history of immunodeficiency;
- Consanguineous parents;
- Multiple births more than twins.
Exclusion
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2025
Estimated Enrollment :
1272 Patients enrolled
Trial Details
Trial ID
NCT01906853
Start Date
July 1 2013
End Date
February 1 2025
Last Update
February 17 2025
Active Locations (2)
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1
Mercy Hospital for Women
Heidelberg, Victoria, Australia, 3084
2
Royal Children's Hospital
Melbourne, Victoria, Australia, 3052