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Focusing on observational cohort study due to limited enrollment in trial
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Enfamil AR | Experimental | This is the group of subjects randomized to receive Enfamil AR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rice cereal | Dietary Supplement | Standard formula thickened with rice cereal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Choking episodes | Frequency of choking episodes | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Choking episodes | Frequency of choking episodes | 12 months |
| Repeat hospital admission | Number of hospitalizations after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel L Rosen, MD, MPH | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27741062 | Background | 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. |
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| ID | Term |
|---|---|
| D057768 | Brief, Resolved, Unexplained Event |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D003490 | Cyanosis |
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| Enfamil AR | Dietary Supplement | Enfamil AR formula |
|
| 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 | 2 months |
| Urine concentration | Change in urine concentration after randomization | 2 months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |