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

NCT03130543 | Terminated

• 1 other identifier: IRB-P00023342
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Apparent Life Threatening Event; Gastroesophageal Reflux; Aspiration

Keywords

Brief resolved unexplained event

Outcome Measures

Primary Outcomes (1)

• Choking episodes

  Frequency of choking episodes

  2 weeks

Secondary Outcomes (4)

• Choking episodes

  12 months

• Repeat hospital admission

  12 months

• Microbiome changes

  2 months

• Urine concentration

  2 months

Study Arms (3)

Standard Formula

NO INTERVENTION

This is the group of subjects randomized to receive their standard formula

Standard Formula with Rice Cereal

EXPERIMENTAL

This is the group of subjects randomized to receive their standard formula with rice cereal added

Dietary Supplement: Rice cereal

Enfamil AR

EXPERIMENTAL

This is the group of subjects randomized to receive Enfamil AR

Dietary Supplement: Enfamil AR

Interventions

Rice cereal DIETARY_SUPPLEMENT

Standard formula thickened with rice cereal

Standard Formula with Rice Cereal

Enfamil AR DIETARY_SUPPLEMENT

Enfamil AR formula

Enfamil AR

Eligibility Criteria

• Age: 0 Years - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 27741062 BACKGROUND

MeSH Terms

Conditions

Brief, Resolved, Unexplained Event; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Cyanosis; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Rachel L Rosen, MD, MPH

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: April 26, 2017
• Study Start: April 24, 2017
• Primary Completion: April 2, 2021
• Study Completion: April 2, 2021
• Last Updated: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)