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

NCT ID: NCT03130543

Last Updated: 2021-04-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-24
• Study Completion Date: 2021-04-02

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Formula

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Standard Formula with Rice Cereal

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

Group Type: EXPERIMENTAL

Rice cereal

Intervention Type: DIETARY_SUPPLEMENT

Standard formula thickened with rice cereal

Enfamil AR

This is the group of subjects randomized to receive Enfamil AR

Group Type: EXPERIMENTAL

Enfamil AR

Intervention Type: DIETARY_SUPPLEMENT

Enfamil AR formula

Interventions

Rice cereal

Standard formula thickened with rice cereal

Intervention Type: DIETARY_SUPPLEMENT

Enfamil AR

Enfamil AR formula

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rachel Rosen

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachel L Rosen, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 27741062 (View on PubMed)

Other Identifiers

IRB-P00023342

Identifier Type: -

Identifier Source: org_study_id