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Impact of Swaddle Blanket on Gastroesophageal Reflux

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ClinicalTrials.gov Identifier: NCT02083952
Recruitment Status : Unknown
Verified January 2015 by Valley Health System.
Recruitment status was:  Recruiting
First Posted : March 11, 2014
Last Update Posted : January 21, 2015
Sponsor:
Information provided by (Responsible Party):
Valley Health System

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Apnea Bradycardia Oxygen Desaturations Other: Swaddle Blanket Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Swaddle Blanket on Gastroesophageal Reflux
Study Start Date : February 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: swaddle blanket Other: Swaddle Blanket
Two arms involve varying time spent in blanket




Primary Outcome Measures :
  1. pH [ Time Frame: 24 hours ]
    all epochs of pH values below 4.0 will be measured


Secondary Outcome Measures :
  1. apnea [ Time Frame: 24 hours ]
    all breathing pauses greater than 20 seconds will be noted


Other Outcome Measures:
  1. bradycardia [ Time Frame: 24 hours ]
    all heart rate drops below 80 beats per minute will be noted

  2. oxygen desaturations [ Time Frame: 24 hours ]
    all oxygen drops below 92% will be noted



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 180 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- NICU patients who have a 5 channel study requested by the attending neonatologist -

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083952


Contacts
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Contact: Mary T Carbone, MD 201-447-8152
Contact: Margaret Bischoff, MSN 201-447-8746 mbischo@valleyhealth.com

Locations
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United States, New Jersey
The Valley Hospital Recruiting
Ridgewood, New Jersey, United States, 07450
Sub-Investigator: Margaret Bischoff         
Sponsors and Collaborators
Valley Health System
Investigators
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Principal Investigator: Mary T Carbone, MD The Valley Hospital
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Responsible Party: Valley Health System
ClinicalTrials.gov Identifier: NCT02083952    
Other Study ID Numbers: 20131959
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Bradycardia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes