An interventional study of Rice cereal and Enfamil AR in Apparent Life Threatening Event, Gastroesophageal Reflux and Aspiration, sponsored by Boston Children's Hospital. Terminated at 1 site in United States. Open to participants aged 0 Years to 1 Year. Per ClinicalTrials.gov, last updated 2021-04-06.
Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
This is the group of subjects randomized to receive their standard formula
This is the group of subjects randomized to receive their standard formula with rice cereal added
Dietary Supplement: Rice cereal
This is the group of subjects randomized to receive Enfamil AR
Dietary Supplement: Enfamil AR
Standard formula thickened with rice cereal
Enfamil AR formula
Choking episodes
Frequency of choking episodes
Time frame: 2 weeks
Choking episodes
Frequency of choking episodes
Time frame: 12 months
Repeat hospital admission
Number of hospitalizations after randomization
Time frame: 12 months
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
Time frame: 2 months
Urine concentration
Change in urine concentration after randomization
Time frame: 2 months
Plan to share: No
This study is terminated, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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