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

A Randomized Trial of Thickened Feeds to Treat Gastroesophageal Reflux in Children Admitted to Boston Children's Hospital After Brief Resolved Unexplained Event

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.

Study Overview

• Status: Terminated
• Conditions: Gastroesophageal Reflux; Aspiration; Apparent Life Threatening Event
• Intervention / Treatment: Dietary supplement: Rice cereal; Dietary supplement: Enfamil AR

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Formula; This is the group of subjects randomized to receive their standard formula
Experimental: Standard Formula with Rice Cereal; This is the group of subjects randomized to receive their standard formula with rice cereal added	Dietary supplement: Rice cereal; Standard formula thickened with rice cereal
Experimental: Enfamil AR; This is the group of subjects randomized to receive Enfamil AR	Dietary supplement: Enfamil AR; Enfamil AR formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Choking episodes	Frequency of choking episodes	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Choking episodes	Frequency of choking episodes	12 months
Repeat hospital admission	Number of hospitalizations after randomization	12 months
Microbiome changes	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	2 months
Urine concentration	Change in urine concentration after randomization	2 months

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Rachel L Rosen, MD, MPH, Boston Children's Hospital

Publications and helpful links

General Publications

• Duncan DR, Amirault J, Mitchell PD, Larson K, Rosen RL. Oropharyngeal Dysphagia Is Strongly Correlated With Apparent Life-Threatening Events. J Pediatr Gastroenterol Nutr. 2017 Aug;65(2):168-172. doi: 10.1097/MPG.0000000000001439.

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2017
• Primary Completion (Actual): April 2, 2021
• Study Completion (Actual): April 2, 2021

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): April 6, 2021
• Last Update Submitted That Met QC Criteria: April 2, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Brief resolved unexplained event
• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Respiration Disorders; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Signs and Symptoms, Respiratory; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophagitis; Peptic Ulcer; Duodenal Diseases; Respiratory Insufficiency; Cyanosis; Gastroesophageal Reflux; Esophagitis, Peptic; Brief, Resolved, Unexplained Event
• Other Study ID Numbers: IRB-P00023342

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No