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Evaluation of a Supervised Clinical Feeding Intervention

NCT06892132 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2025-03-24

No results posted yet for this study

Summary

Peanut allergies affect approximately 2.5% of children; are associated with significant mortality, morbidity, and economic costs; and often lead to persistent peanut allergies in adulthood. We now know however that early introduction of peanut products to infants prior to age 7 months and maintained in the diet regularly significantly reduces the rate of peanut allergies. Unfortunately, recent research shows that even when parents know the recommendations to feed peanut products early and often, \<50% of parents report introducing peanuts by age 9 months, \<45% are offering peanut products several times a week, and \<20% are offering the recommended 2 teaspoons at each feeding. Many parents cite a fear of reactions or a lack of knowledge on how to safely feed peanut products at this age. While there are recommendations to offer the first feeding in clinic this has not been widely implemented in general pediatrics clinics and we have no research to say this is an effective way to increase peanut consumption at home. This research is being conducted to assess the effectiveness of a supervised peanut feeding clinic in a pediatric office to increase rate of guideline recommended peanut consumption in infants by 9 months of age.

Conditions

  • Peanut Allergies in Children

Interventions

OTHER

Supervised feeding intervention

Participants will be fed a peanut product during a supervised feeding visit and observed for an allergic reaction.

OTHER

Handout

Participants will receive a handout on how to introduce peanut products.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2026-08-31
Completion
2027-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06892132 on ClinicalTrials.gov