Evaluation of a Supervised Clinical Feeding Intervention

NCT06892132 | Not Yet Recruiting

• 1 other identifier: P00050109
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Peanut introduction at 9 months

  Percentage of families who have introduced peanut products at home in 2 groups.

  3 months

Secondary Outcomes (1)

• Frequency of peanut introduction

  3 months

Study Arms (2)

Control

ACTIVE COMPARATOR

Families will receive guidance about early peanut introduction via a handout.

Other: Handout

Intervention

EXPERIMENTAL

Families will receive guidance about early peanut introduction via handout as well as a supervised feeding visit.

Other: Supervised feeding intervention

Interventions

Supervised feeding intervention OTHER

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

Intervention

Handout OTHER

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

Control

Eligibility Criteria

• Age: 4 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Central Study Contacts

Zara Atal, MD

CONTACT

646-256-6619; zara.atal@childrens.harvard.edu

Corinna Rea, MD, MPH

CONTACT

617-355-4188; corinna.rea@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 24, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

US (1)