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TreEAT Trial: protocol for a randomised controlled trial investigating the efficacy and safety of early introduction of tree nuts for the prevention of tree nut allergy in infants with peanut allergy.
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  • Vicki Mc William,
  • Jennifer Koplin,
  • Katie Allen,
  • Marnie Robinson,
  • joanne smart,
  • Paxton Loke,
  • Rachel Peters,
  • Thanh Dang,
  • Katherine Lee,
  • Kim Dalziel,
  • Dean Tey,
  • Mark Taranto,
  • Kirsten Perrett
Vicki Mc William
Murdoch Children's Research Institute

Corresponding Author:[email protected]

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Jennifer Koplin
Murdoch Children's Research Institute
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Katie Allen
Murdoch Children's Research Institute
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Marnie Robinson
The Royal Children's Hospital Melbourne
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joanne smart
The Royal Children's Hospital Melbourne
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Paxton Loke
The Royal Children's Hospital Melbourne
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Rachel Peters
Murdoch Children's Research Institute
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Thanh Dang
Murdoch Children's Research Institute
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Katherine Lee
Murdoch Children's Research Institute
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Kim Dalziel
The University of Melbourne Research
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Dean Tey
The Royal Children's Hospital Melbourne
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Mark Taranto
The Royal Children's Hospital Melbourne
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Kirsten Perrett
Murdoch Children's Research Institute
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Abstract

Introduction: Children with peanut allergy are at increased risk of developing tree nut allergies, which can be severe and for most lifelong. Introduction of peanut in the first year of life can reduce the risk of peanut allergy, however, prevention strategies for tree nut allergies have not been established. We aimed to test the efficacy and safety of a novel strategy, a supervised multi-nut oral food challenge (OFC) compared to standard care for tree nut allergy prevention in infants at high risk of developing tree nut allergy, TreEAT. Methods and analysis: TreEAT is a 2-armed, open-label, randomised, controlled trial (RCT). Infants (n=212) aged 4-11months with peanut allergy will be randomised 1:1 at peanut allergy diagnosis to either a hospital-based multi-tree nut (almond, cashew, hazelnut and walnut) OFC using multi-nut butter or standard care (home introduction of individual tree nuts). All infants will be assessed at age 18months, with questionnaires and SPT to peanut and tree nuts. Peanut and tree nut OFCs will be performed as required to determine allergy status for each nut. The primary outcome is tree nut allergy at age 18 months. Secondary outcomes include peanut allergy resolution, proportion and severity of adverse events related to tree nut ingestion, number and frequency of tree nuts ingested, quality of life and parental anxiety and allergy related healthcare visits from randomisation to 18 months of age. Analyses will be performed on an intention-to-treat basis. Ethics and dissemination TreEAT was approved by the Royal Children’s Hospital Human Research Ethics Committee (#70489). Outcomes will be presented at scientific conferences and disseminated through publication. Trial registration number: ClinicalTrials.gov ID: NCT04801823
16 Aug 2022Submitted to Pediatric Allergy and Immunology
17 Sep 2022Reviewer(s) Assigned
13 Oct 2022Review(s) Completed, Editorial Evaluation Pending
23 Oct 2022Editorial Decision: Revise Major
26 Dec 20221st Revision Received
26 Dec 2022Submission Checks Completed
26 Dec 2022Assigned to Editor
26 Dec 2022Review(s) Completed, Editorial Evaluation Pending
31 Dec 2022Reviewer(s) Assigned
20 Feb 2023Editorial Decision: Accept