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NCT04604431 · ClinicalTrials.gov registry record · NA
Intervention to Reduce Early (Peanut) Allergy in Children
A NA study of Food Allergy in Infants and Food Allergy Peanut, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- Active
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 20
- Study locations
NCT04604431: Active NA study of Food Allergy in Infants and Food Allergy Peanut, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
NCT04604431 is a NA study of Food Allergy in Infants and Food Allergy Peanut that is active but no longer recruiting, run by Ann & Robert H Lurie Children's Hospital of Chicago. The registered enrollment target is 30 participants, below the 4,974-participant average among 5 other Food Allergy in Infants trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04604431, a NA study of Food Allergy in Infants and Food Allergy Peanut, is active but no longer recruiting, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 20
- Study locations
Study Summary
iREACH is a five-year NIH funded study aimed at assessing and improving pediatric clinician adherence to the 2017 NIAID Prevention of Peanut Allergy (PPA) Guidelines. iREACH has been developed as an electronic health record (EHR) integrated Clinical Decision Support (CDS) tool together with educational modules on the PPA guidelines to assist clinicians in implementing the 2017 NIAID PPA Guidelines. A practice-based, two-arm, cluster-randomized clinical trial will evaluate the effectiveness of iREACH in increasing pediatric clinician adherence to the PPA Guidelines and explore the end-goal of reducing peanut allergy incidence by age 2.5 years in the intervention vs control group. This study has the potential to: 1) provide evidence regarding the effectiveness of iREACH in promoting clinical processes and outcomes related to the PPA Guidelines, 2) provide important insight about practice-based implementation of PPA Guidelines by pediatric clinicians, allergists and caregivers, and 3) facilitate rapid, widespread implementation of PPA Guidelines and reduce peanut allergy incidence across the US.
Primary Outcome
The primary endpoint is the percentage of infants within each trial arm whose pediatric clinician adhered to the guidelines regarding peanut introduction assessed after completion of either a 4- or 6-month WCC. The primary endpoint concerns only the peanut introduction recommendation by the treating pediatric clinician and not additional behavior by the treating allergist or by caregivers. The primary endpoint will be measured separately by risk category as follows: * % of infants at low risk f
Conditions Studied
Interventions
- OTHER iREACH CDS Tool
Study Locations (20)
Illinois
- Pediatric Associates of Arlington Heights, SC-PEDIATRUST - Arlington Heights
- OSF Medical Group Pediatrics Bloomington - Bloomington
- Child and Adolescent Health Associates - Chicago
- Northwestern Children's Practice - Chicago
- Streeterville Pediatrics - Chicago
- Erie Family Health Centers - Erie Teen and Young Adult Health Center - Chicago
- Erie Family Health Centers - West Town - Chicago
- Erie Family Health Centers - Helping Hands - Foster - Chicago
- Lurie Children's Primary Care Town & Country Pediatrics - Chicago
- Near North Health Services Corporation - Chicago
- Children's Health Associates - Chicago
- Lakeview Pediatrics - Chicago
- OSF Medical Group Pediatrics Danville - Danville
- Erie Family Health Centers - Evanston - Evanston
- Lurie Children's Primary Care Chicago Area Pediatrics - Evanston
- OSF Medical Group Pediatrics Godfrey - Godfrey
- Pediatric Partners, SC-PEDIATRUST - Highland Park
- Bedrose Pediatrics - Hoffman Estates
- Lake Shore Pediatrics, SC-PEDIATRUST - Libertyville
- OSF Medical Group (MG)-Morton Pediatrics - Morton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2020-11-04 |
| Est. Completion | 2025-12-31 |
| Phase | NA |
What the registry record for NCT04604431 still lists
NCT04604431 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 4,974-participant average among 5 other Food Allergy in Infants trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Food Allergy in Infants appearing as the primary indexed condition, and to 1 intervention - of which iREACH CDS Tool is the first listed.
NCT04604431 names 20 study sites across 1 states, led by Illinois.
Frequently Asked Questions
What is clinical trial NCT04604431 about?
NCT04604431 is a clinical study titled "Intervention to Reduce Early (Peanut) Allergy in Children". iREACH is a five-year NIH funded study aimed at assessing and improving pediatric clinician adherence to the 2017 NIAID Prevention of Peanut Allergy (PPA) Guidelines. iREACH has been developed as an electronic health record (EHR) integrated Clinical Decision Support (CDS) tool together with educati...
What is the current status of trial NCT04604431?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2020-11-04. Estimated completion is 2025-12-31.
What conditions does trial NCT04604431 study?
This clinical trial studies the following conditions: Food Allergy in Infants, Food Allergy Peanut.
What interventions are being tested in trial NCT04604431?
The interventions under investigation include: iREACH CDS Tool (OTHER).
Who is sponsoring clinical trial NCT04604431?
This trial is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago, which has 159 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04604431 being conducted?
This trial has 20 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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