Evaluation of a Supervised Clinical Feeding Intervention

Conditions

• Peanut Allergies in Children

Eligibility Criteria

Sex

ALL

Age

4 Months - 6 Months

Healthy Volunteers

Accepted

Interventions

• Supervised feeding intervention — OTHER
  Participants will be fed a peanut product during a supervised feeding visit and observed for an allergic reaction.
• Handout — OTHER
  Participants will receive a handout on how to introduce peanut products.

Study Details

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.

Key Dates

Start date

May 1, 2025

Status verified

Mar 2025

Primary completion

Aug 31, 2026

Completion

Aug 31, 2027

Study Design

Enrollment

320 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: Control
  Families will receive guidance about early peanut introduction via a handout.
• Experimental: Intervention
  Families will receive guidance about early peanut introduction via handout as well as a supervised feeding visit.

Primary Outcome Measure

Peanut introduction at 9 months [ Time Frame: 3 months ]

Central Contacts

• Zara Atal, MD
  646-256-6619
  [email protected]
• Corinna Rea, MD, MPH
  617-355-4188
  [email protected]

Locations (1)

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