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

Gastroesophageal Reflux Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03130543
• Other study ID #: IRB-P00023342
• Status: Terminated
• Phase: N/A
• Start date: April 24, 2017
• Est. completion date: April 2, 2021

Study information

• Verified date: April 2021
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: April 2, 2021
• Est. primary completion date: April 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Apparent Life Threatening Event
• Aspiration
• Esophagitis, Peptic
• Gastroesophageal Reflux

Intervention

Dietary Supplement:
• Rice cereal
Standard formula thickened with rice cereal
• Enfamil AR
Enfamil AR formula

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Choking episodes	Frequency of choking episodes	2 weeks
Secondary	Choking episodes	Frequency of choking episodes	12 months
Secondary	Repeat hospital admission	Number of hospitalizations after randomization	12 months
Secondary	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
Secondary	Urine concentration	Change in urine concentration after randomization	2 months