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NCT03130543 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Boston Children's Hospital.

Terminated
Registry status
NA
Development phase
3
Enrollment target

NCT03130543 is a NA study that was terminated before completion, run by Boston Children's Hospital. The registered enrollment target is 3 participants.

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The verdict

NCT03130543, a NA study, was terminated before completion, sponsored by Boston Children's Hospital.

TERMINATED
Registry status
NA
Development phase
3 participants
Enrollment target

Study 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.

Interventions

  • DIETARY_SUPPLEMENT Rice cereal
  • DIETARY_SUPPLEMENT Enfamil AR

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2017-04-24
Est. Completion 2021-04-02
Phase NA

Sponsor

Boston Children's Hospital

462 total trials

What the Registry Record Tells You About NCT03130543

The ClinicalTrials.gov registry entry for NCT03130543 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Rice cereal is the first listed.

NCT03130543 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03130543 about?

NCT03130543 is a clinical study titled "A Trial of Thickened Feeds to Treat Gastroesophageal Reflux in Children Admitted After Choking Spell". 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 ag...

What is the current status of trial NCT03130543?

This trial is currently terminated. It is a NA study. The enrollment target is 3 participants. The study started on 2017-04-24. Estimated completion is 2021-04-02.

What interventions are being tested in trial NCT03130543?

The interventions under investigation include: Rice cereal (DIETARY_SUPPLEMENT), Enfamil AR (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT03130543?

This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.