Gastroesophageal RefluxNCT02083952
Impact of Swaddle Blanket on Gastroesophageal Reflux
A study testing Swaddle Blanket in people with Gastroesophageal Reflux and Apnea, run by Valley Health System at 1 site in United States.
Trial summary
Gastroesophageal reflux disease (GERD) has been reported in up to 85% of all infants born prematurely, and has been associated with a wide range of symptoms. These include irritability, pauses in breathing, heart rate drops, declines in oxygen levels, chronic lung disease, and delays in growth and development. Read more about this study
- Who is it for?
- Ages 2 to 180 days
- Conditions the study is for
- Gastroesophageal Reflux, Apnea, Bradycardia
- What is being tested?
- Swaddle Blanket
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Oct 2015
- 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 2 to 180 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- NICU patients who have a 5 channel study requested by the attending neonatologist -
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Gastroesophageal reflux disease (GERD) has been reported in up to 85% of all infants born prematurely, and has been associated with a wide range of symptoms. These include irritability, pauses in breathing, heart rate drops, declines in oxygen levels, chronic lung disease, and delays in growth and development. A novel approach to the mangement of GERD in infants is the use of an abdominal band, applying gentle pressure and possibly reducing the reflux of acid from the stomach. The purpose of this study is to evaluate the impact of a swaddle blanket with an abdominal band insert on the incidence of infant apnea, bradycardia, oxygen declines, and pH (acid) changes.
- Conditions
- Gastroesophageal Reflux, Apnea, Bradycardia, Oxygen Desaturations
- Being tested
- Swaddle Blanket
- Medical subject headings
- Gastroesophageal Reflux, Apnea, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swaddle BlanketOther
Two arms involve varying time spent in blanket
| Study group | Role | What they receive |
|---|---|---|
| swaddle blanket | Experimental | Not described Receives: Other: Swaddle Blanket |
What is being measured
The primary outcome is the main question the study is designed to answer.
pH
all epochs of pH values below 4.0 will be measured
Measured: 24 hours
Secondary outcomes (1)
apnea
all breathing pauses greater than 20 seconds will be noted
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valley Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary T Carbone, MD, Principal investigator, The Valley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083952
- Sponsor's protocol ID
- 20131959
- Status last verified
- Oct 2015
- First submitted
- 4 Mar 2014
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Swaddle Blanket on Gastroesophageal Reflux
- ClinicalTrials.gov ID
- NCT02083952
- Acronym / sponsor ID
- 20131959
- Conditions
- Gastroesophageal Reflux, Apnea, Bradycardia, Oxygen Desaturations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Valley Health SystemUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 11 Mar 2014 (estimated)
- 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.
Gastroesophageal reflux disease (GERD) has been reported in up to 85% of all infants born prematurely, and has been associated with a wide range of symptoms. These include irritability, pauses in breathing, heart rate drops, declines in oxygen levels, chronic lung disease, and delays in growth and development. A novel approach to the mangement of GERD in infants is the use of an abdominal band, applying gentle pressure and possibly reducing the reflux of acid from the stomach. The purpose of this study is to evaluate the impact of a swaddle blanket with an abdominal band insert on the incidence of infant apnea, bradycardia, oxygen declines, and pH (acid) changes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| swaddle blanket | Experimental | Other: Swaddle Blanket |
Who may qualify
- Ages
- 2 to 180 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- NICU patients who have a 5 channel study requested by the attending neonatologist -
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Swaddle BlanketTwo arms involve varying time spent in blanket | Other | swaddle blanket |
Primary outcome
pH
Time frame: 24 hours
all epochs of pH values below 4.0 will be measured
1 secondary outcome
apnea
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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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.
Mary T Carbone, MD principal investigator
The Valley 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 Swaddle Blanket in people with Gastroesophageal Reflux and Apnea, run by Valley Health System 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 1 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: finished, as of the sponsor's last update on 5 Jun 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
pH (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2026.