A Trial of Thickened Feeds to Treat Gastroesophageal Reflux in Children Admitted After Choking Spell

Not Applicable

Terminated

• Conditions: Aspiration; Gastroesophageal Reflux; Apparent Life Threatening Event
• Interventions: Dietary Supplement: Enfamil AR; Dietary Supplement: Rice cereal

• Registration Number: NCT03130543
• Lead Sponsor: Boston Children's Hospital

Brief Summary

Infants often present to the hospital with episodes of coughing, choking, gagging, change in muscle tone, and/or change in skin color, known as brief resolved unexplained event. Many studies have tried to address why infants have these symptoms and if there is a way to prevent them from happening again. Currently, there is no clear agreement on the most common cause of these symptoms or how to prevent them. Some studies have suggested that gastroesophageal reflux can cause these symptoms. The investigators are conducting a study of infants who are admitted to Boston Children's Hospital with episodes of coughing, choking, gagging, change in muscle tone, and/or change in skin color, symptoms that could be reflux. The investigators want to determine if these symptoms can be prevented by changing the way infants are fed, either by giving them a formula to treat reflux or by thickening their feeds to treat reflux. The goal of the study is to determine if different types of feeding interventions prevent infants from coming back to the hospital.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-06
• Study Start: 2017-04-24
• Study First Submitted QC: 2017-04-24
• Study First Posted: 2017-04-26
• Status Verified: 2021-04
• Primary Completion: 2021-04-02
• Study Completion: 2021-04-02
• Last Update Submitted: 2021-04-02
• Last Update Posted: 2021-04-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Patients less than 12 months of age who have been admitted to the hospital after brief resolved unexplained event

Exclusion Criteria

• Patients with any pre-existing significant medical diagnosis (congenital heart disease, known neurologic impairment with or without seizure disorder, other congenital anomalies)
• Patients with any prior hospitalization for BRUE
• Patients with food allergies such that they cannot be on a milk or rice based diet
• Any patient exclusively breastfed because change to a formula or adding thickening is not possible unless patients choose to pump breast milk and stop all nursing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enfamil AR	Enfamil AR	This is the group of subjects randomized to receive Enfamil AR
Standard Formula with Rice Cereal	Rice cereal	This is the group of subjects randomized to receive their standard formula with rice cereal added

Primary Outcome Measures

Name	Time	Method
Choking episodes	2 weeks	Frequency of choking episodes

Secondary Outcome Measures

Name	Time	Method
Repeat hospital admission	12 months	Number of hospitalizations after randomization
Microbiome changes	2 months	Prior studies have suggested that infant thickeners can be associated with necrotizing enterocolitis in infants; the aim of this secondary outcome measure will be to evaluate for changes in microbiome (particularly toward a more pathogenic microbiome) after randomization
Urine concentration	2 months	Change in urine concentration after randomization
Choking episodes	12 months	Frequency of choking episodes

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States