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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:
Sponsor: Boston Children’s Hospital

Current Primary Outcome: Choking episodes [ Time Frame: 2 weeks ]

Frequency of choking episodes


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Choking episodes [ Time Frame: 12 months ]
    Frequency of choking episodes
  • Repeat hospital admission [ Time Frame: 12 months ]
    Number of hospitalizations after randomization
  • Microbiome changes [ Time Frame: 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 [ Time Frame: 2 months ]
    Change in urine concentration after randomization


Original Secondary Outcome: Same as current

Information By: Boston Children’s Hospital

Dates:
Date Received: March 6, 2017
Date Started: April 24, 2017
Date Completion: March 6, 2022
Last Updated: April 24, 2017
Last Verified: April 2017