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

Sponsor

Boston Children's Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT03130543

Collaborator

(none)

Enrollment

Location

Arms

47.3

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Apparent Life Threatening Event Gastroesophageal Reflux Aspiration	Dietary Supplement: Rice cereal Dietary Supplement: Enfamil AR	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 24, 2017

Actual Primary Completion Date :

Apr 2, 2021

Actual Study Completion Date :

Apr 2, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Choking episodes [2 weeks]
Frequency of choking episodes

Secondary Outcome Measures

Choking episodes [12 months]
Frequency of choking episodes
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 1 Year

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston Children's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

Boston Children's Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Rachel Rosen, Associate Professor of Pediatrics, Boston Children's Hospital

ClinicalTrials.gov Identifier:

NCT03130543

Other Study ID Numbers:

IRB-P00023342

First Posted:

Apr 26, 2017

Last Update Posted:

Apr 6, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Rachel Rosen, Associate Professor of Pediatrics, Boston Children's Hospital

Brief resolved unexplained event

Additional relevant MeSH terms:

Gastroesophageal Reflux

Esophagitis, Peptic

Brief, Resolved, Unexplained Event

Study Results

No Results Posted as of Apr 6, 2021