Back to resultsImpact of Swaddle Blanket on Gastroesophageal Reflux
Primary Purpose
Gastroesophageal Reflux, Apnea, Bradycardia
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Swaddle Blanket
Sponsored by
About this trial
This is an interventional prevention trial for Gastroesophageal Reflux
Eligibility Criteria
Inclusion Criteria:
- NICU patients who have a 5 channel study requested by the attending neonatologist -
Exclusion Criteria:
-
Sites / Locations
- The Valley HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
swaddle blanket
Arm Description
Outcomes
Primary Outcome Measures
pH
all epochs of pH values below 4.0 will be measured
Secondary Outcome Measures
apnea
all breathing pauses greater than 20 seconds will be noted
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02083952
Brief Title
Impact of Swaddle Blanket on Gastroesophageal Reflux
Official Title
Impact of Swaddle Blanket on Gastroesophageal Reflux
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valley Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux, Apnea, Bradycardia, Oxygen Desaturations
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
swaddle blanket
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Swaddle Blanket
Intervention Description
Two arms involve varying time spent in blanket
Primary Outcome Measure Information:
Title
pH
Description
all epochs of pH values below 4.0 will be measured
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
apnea
Description
all breathing pauses greater than 20 seconds will be noted
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
bradycardia
Description
all heart rate drops below 80 beats per minute will be noted
Time Frame
24 hours
Title
oxygen desaturations
Description
all oxygen drops below 92% will be noted
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Days
Maximum Age & Unit of Time
180 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- NICU patients who have a 5 channel study requested by the attending neonatologist -
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary T Carbone, MD
Phone
201-447-8152
First Name & Middle Initial & Last Name or Official Title & Degree
Margaret Bischoff, MSN
Phone
201-447-8746
Email
mbischo@valleyhealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary T Carbone, MD
Organizational Affiliation
The Valley Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Bischoff
12. IPD Sharing Statement
Learn more about this trial
Impact of Swaddle Blanket on Gastroesophageal Reflux
We'll reach out to this number within 24 hrs