Apparent Life Threatening EventNCT03130543
A Trial of Thickened Feeds to Treat Gastroesophageal Reflux in Children Admitted After Choking Spell
A study testing Rice cereal and Enfamil AR in people with Apparent Life Threatening Event and Gastroesophageal Reflux, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years to 1 year
- Conditions the study is for
- Apparent Life Threatening Event, Gastroesophageal Reflux, Aspiration
- What is being tested?
- Rice cereal and Enfamil AR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2017to 2 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients less than 12 months of age who have been admitted to the hospital after brief resolved unexplained event
Who cannot join
- Patients with any pre-existing significant medical diagnosis (congenital heart disease, known neurologic impairment with or without seizure disorder, other congenital anomalies)
- Patients with any prior hospitalization for BRUE
- Patients with food allergies such that they cannot be on a milk or rice based diet
- Any patient exclusively breastfed because change to a formula or adding thickening is not possible unless patients choose to pump breast milk and stop all nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Randomized Trial of Thickened Feeds to Treat Gastroesophageal Reflux in Children Admitted to Boston Children's Hospital After Brief Resolved Unexplained Event
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.
- Being tested
- Rice cereal, Enfamil AR
- Keywords
- Brief resolved unexplained event
- Medical subject headings
- Brief, Resolved, Unexplained Event, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rice cerealDietary supplement
Standard formula thickened with rice cereal
Enfamil ARDietary supplement
Enfamil AR formula
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Rice cereal |
| Enfamil AR | Experimental | This is the group of subjects randomized to receive Enfamil AR Receives: Dietary Supplement: Enfamil AR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choking episodes
Frequency of choking episodes
Measured: 2 weeks
Secondary outcomes (4)
Choking episodes
Frequency of choking episodes
Measured: 12 months
Repeat hospital admission
Number of hospitalizations after randomization
Measured: 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
Measured: 2 months
Urine concentration
Change in urine concentration after randomization
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start24 Apr 2017
- Primary completion2 Apr 2021
- Study completion2 Apr 2021
Why it stopped: Focusing on observational cohort study due to limited enrollment in trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Apparent Life Threatening EventStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Rosen, Boston Children's Hospital
- Investigators
- Rachel L Rosen, MD, MPH, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130543
- Sponsor's protocol ID
- IRB-P00023342
- Status last verified
- Apr 2021
- First submitted
- 6 Mar 2017
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27741062
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Thickened Feeds to Treat Gastroesophageal Reflux in Children Admitted to Boston Children's Hospital After Brief Resolved Unexplained Event
- ClinicalTrials.gov ID
- NCT03130543
- Acronym / sponsor ID
- IRB-P00023342
- Keywords
- Brief resolved unexplained event
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Focusing on observational cohort study due to limited enrollment in trial
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 2 Apr 2021 (actual)
- Study completion
- 2 Apr 2021 (actual)
- First posted
- 26 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Formula | No intervention | –This is the group of subjects randomized to receive their standard formula |
| Standard Formula with Rice Cereal | Experimental | Dietary Supplement: Rice cerealThis is the group of subjects randomized to receive their standard formula with rice cereal added |
| Enfamil AR | Experimental | Dietary Supplement: Enfamil ARThis is the group of subjects randomized to receive Enfamil AR |
Who may qualify
- Ages
- 0 years to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients less than 12 months of age who have been admitted to the hospital after brief resolved unexplained event
Key exclusion criteria (4 listed)
- Patients with any pre-existing significant medical diagnosis (congenital heart disease, known neurologic impairment with or without seizure disorder, other congenital anomalies)
- Patients with any prior hospitalization for BRUE
- Patients with food allergies such that they cannot be on a milk or rice based diet
- Any patient exclusively breastfed because change to a formula or adding thickening is not possible unless patients choose to pump breast milk and stop all nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rice cerealStandard formula thickened with rice cereal | Dietary supplement | Standard Formula with Rice Cereal |
| Enfamil AREnfamil AR formula | Dietary supplement | Enfamil AR |
Primary outcome
Choking episodes
Time frame: 2 weeks
Frequency of choking episodes
4 secondary outcomes
Choking episodes
Time frame: 12 months
Repeat hospital admission
Time frame: 12 months
Microbiome changes
Time frame: 2 months
Urine concentration
Time frame: 2 months
Results and safety
The study was stopped early (reason given: Focusing on observational cohort study due to limited enrollment in trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Background: PubMed 27741062Duncan 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.
- Individual participant dataSharing planned: No
Related trials for Apparent Life Threatening Event
RecruitingObservational study
Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event
Brief Resolved Unexplained Event, Apparent Life Threatening Event
Recruiting
Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia
Dysphagia, Aspiration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel L Rosen, MD, MPH principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rice cereal and Enfamil AR in people with Apparent Life Threatening Event and Gastroesophageal Reflux, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Focusing on observational cohort study due to limited enrollment in trial). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Choking episodes (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03130543, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.