Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K23DK127251 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
This observational study will examine the effects of thickened feeds on clinical outcomes and healthcare utilization in infants with brief resolved unexplained event (BRUE).
Brief resolved unexplained events (BRUE) are frightening episodes characterized by the appearance of life-threatening choking, pallor, cyanosis, and limpness in infants. These common events are resource-intensive and current management approaches inadequately address persistent symptoms. Infants with BRUE commonly have oropharyngeal dysphagia with aspiration, which is a modifiable risk factor for persistent symptoms, but there are no studies determining the mechanism behind this swallowing dysfunction and if swallowing interventions reduce morbidity. This is a prospective, longitudinal cohort study of infants who experienced brief resolved unexplained event receiving thickened feedings compared to those not receiving thickened feedings over 1 year.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infants with BRUE receiving thickened feeds |
| ||
| Infants with BRUE not receiving thickened feeds |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thickened feeds | Dietary Supplement | Thickened feeds directed by medical team |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of persistent symptoms and repeat hospitalizations over 6-month follow-up period | Frequency of persistent symptoms and repeat hospitalizations over the 6 months after enrollment, with a comparison between those receiving and not receiving thickened feeds. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of persistent symptoms and hospitalization risk over the full 12-month follow-up period | Symptoms and hospitalization risk over the full 12-month follow-up period, optimal period of time needed for thickening, parent-reported anxiety levels, cost of care at Boston Children's Hospital, potential adverse effects of thickening, and urine arsenic levels, all compared between subjects receiving and not receiving thickened feeds. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Participants will be eligible for the study if they are less than 1 year of age and admitted to Boston Children's Hospital after experiencing first lifetime BRUE
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel R Duncan, MD, MPH | Contact | 6173550897 | daniel.duncan@childrens.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Daniel R Duncan, MD, MPH | Boston Children's Hospital | Principal Investigator |
| Rachel Rosen, MD, MPH | Boston Children's Hospital | Study Director |
| Sudarshan Jadcherla, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31103259 | Background | Duncan DR, Growdon AS, Liu E, Larson K, Gonzalez M, Norris K, Rosen RL. The Impact of the American Academy of Pediatrics Brief Resolved Unexplained Event Guidelines on Gastrointestinal Testing and Prescribing Practices. J Pediatr. 2019 Aug;211:112-119.e4. doi: 10.1016/j.jpeds.2019.04.007. Epub 2019 May 15. | |
| 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D057768 | Brief, Resolved, Unexplained Event |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D003490 | Cyanosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Urine samples
| Non-thickened feeds | Dietary Supplement | Non-thickened feeds directed by medical team |
|
| 12 months |
| Nationwide Children's Hospital |
| Study Director |
| Taher Omari, PhD | Flinders University | Study Director |
| Samuel Nurko, MD, MPH | Boston Children's Hospital | Study Director |
| 36336644 | Background | Duncan DR, Liu E, Growdon AS, Larson K, Rosen RL. A Prospective Study of Brief Resolved Unexplained Events: Risk Factors for Persistent Symptoms. Hosp Pediatr. 2022 Dec 1;12(12):1030-1043. doi: 10.1542/hpeds.2022-006550. |
| 38815745 | Derived | Duncan DR, Golden C, Growdon AS, Larson K, Rosen RL. Brief Resolved Unexplained Events Symptoms Frequently Result in Inappropriate Gastrointestinal Diagnoses and Treatment. J Pediatr. 2024 Sep;272:114128. doi: 10.1016/j.jpeds.2024.114128. Epub 2024 May 28. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |