Eating nuts while breastfeeding – the Nuts For Babies Study.

Not Applicable

Recruiting

Conditions: IgE-mediated peanut allergy
IgE-mediated cashew nut allergy
Inflammatory and Immune System - Allergies

Registration Number: ACTRN12624000134527

Lead Sponsor: Telethon Kids Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 742

Inclusion Criteria

Women with a singleton pregnancy, who are planning to breastfeed, and where the infant has a high-risk of developing nut allergies due to a family history of eczema/atopic dermatitis, IgE-mediated food allergy and/or hay fever (allergic rhinitis) in at least one of the infant’s biological parents (mother and/or father) or full-sibling (child with the same biological mother and father).

Exclusion Criteria

Women with a peanut and/or cashew nut allergy, as they would be unable to safely follow the intervention without an allergic reaction. Women who have already participated in the Nuts For Babies Study with a previous child.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of infants with IgE-mediated peanut and/or cashew nut allergy - this is a composite primary outcome.[Positive peanut/cashew nut allergen skin prick test and positive peanut/cashew nut oral food challenge. At 12 months of age]

Secondary Outcome Measures

Name	Time	Method
The proportion of infants with IgE-mediated peanut allergy [Positive peanut allergen skin prick test and positive peanut oral food challenge At 12 months of age];The proportion of infants with IgE-mediated cashew nut allergy[Positive cashew nut allergen skin prick test and positive cashew nut oral food challenge At 12 months of age];The proportion of infants with allergic sensitisation to peanut [Positive peanut allergen skin prick test At 12 months of age];The proportion of infants with allergic sensitisation to cashew nut [Positive cashew nut allergen skin prick test At 12 months of age];The proportion of infants with allergic sensitisation to almond [Positive almond allergen skin prick test At 12 months of age];The proportion of infants with allergic sensitisation to hazelnut[Positive hazelnut allergen skin prick test At 12 months of age];The proportion of infants with a medical diagnosis of eczema [Parent report that a medical practitioner has diagnosed infant eczema. At 3, 6, 9 and 12 months of age]