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Could a simple swaddle ease dangerous reflux in preemies?

NCT ID NCT02083952

Symptom relief Sponsor: Valley Health System Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a swaddle blanket with a gentle abdominal band can reduce acid reflux, breathing pauses, heart rate drops, and low oxygen levels in premature infants. About 50 babies in the NICU were observed to see if the blanket helped. The goal was to find a simple, non-drug way to manage reflux symptoms.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Feb 2014

Finished

Oct 2015

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 180 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: \- NICU patients who have a 5 channel study requested by the attending neonatologist - Exclusion Criteria: \-

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Conditions

The condition(s) this trial relates to.

Apnea Bradycardia gastroesophageal reflux disease sleep apnea syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Apnea Bradycardia Gastroesophageal reflux Oxygen desaturations

Contacts and locations

Locations

  • The Valley Hospital

    Ridgewood, New Jersey, 07450, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.