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NCT03130543
A Trial of Thickened Feeds to Treat Gastroesophageal Reflux in Children Admitted After Choking Spell
NA trial testing Rice cereal in Apparent Life Threatening Event in 3 participants. Terminated before completion.
2 April 2021
Quick facts
| Lead sponsor | Boston Children's Hospital |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 3 |
| Start date | 24 April 2017 |
| Primary completion | 2 April 2021 |
| Estimated completion | 2 April 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Rice cereal
- Enfamil AR
Conditions studied
- Apparent Life Threatening Event — all drugs for Apparent Life Threatening Event →
- Gastroesophageal Reflux — all drugs for Gastroesophageal Reflux →
- Aspiration — all drugs for Aspiration →
Sponsor
Boston Children's Hospital
Who can join
Adults 0 to 1, any sex, with Apparent Life Threatening Event or Gastroesophageal Reflux. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03130543
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Related trials
Other recruiting trials for Apparent Life Threatening Event
Currently open trials in the same condition.
- NCT04477460 — Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event · recruiting
Other Boston Children's Hospital trials
Trials by the same sponsor.
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- NCT06706336 — Radon Asthma Intervention Trial · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03130543 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Boston Children's Hospital
- Last refreshed: 6 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03130543.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing