Back to resultsMusic and Feeding in NICU
Primary Purpose
Feeding, NICU, Preterm Infants
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music
No music.
Sponsored by
About this trial
This is an interventional basic science trial for Feeding
Eligibility Criteria
Inclusion Criteria:
• Neonates between the gestational ages of 28 weeks and 32 weeks and 6 days
- Parents ≥18 years of age
- English speaking parents
- Breastmilk as intended primary form of nutrition
Exclusion Criteria:
- Congenital anomalies affecting hearing or feeding skills
- Patients requiring HFOV or HFJV
Sites / Locations
- Christiana Care Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Music
Control
Arm Description
Exposure to music, twice per day for the study period
No intervention; standard care.
Outcomes
Primary Outcome Measures
The primary outcome is time to regain birth weight
We will track weight gain and will monitor how long it takes for the babies to regain their birth weight.
Secondary Outcome Measures
Assessment of Feeding Cues
At 33 weeks corrected gestational age; a speech therapist will assess feeding cues daily using an objective oral feeding assessment tool
Full Information
NCT ID
NCT02919358
First Posted
September 27, 2016
Last Updated
May 15, 2018
Sponsor
Christiana Care Health Services
1. Study Identification
Unique Protocol Identification Number
NCT02919358
Brief Title
Music and Feeding in NICU
Official Title
The Mozart Effect and the Assessment of Weight Gain and Development of Feeding Skills in the NICU.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Christiana Care Health Services
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the effect of classical music exposure on improved time to regain birth weight and improved feeding readiness in healthy premature infants in the NICU.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding, NICU, Preterm Infants, Mozart, Weight Gain
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music
Arm Type
Experimental
Arm Description
Exposure to music, twice per day for the study period
Arm Title
Control
Arm Type
Other
Arm Description
No intervention; standard care.
Intervention Type
Other
Intervention Name(s)
Music
Intervention Type
Other
Intervention Name(s)
No music.
Intervention Description
This is the control group.
Primary Outcome Measure Information:
Title
The primary outcome is time to regain birth weight
Description
We will track weight gain and will monitor how long it takes for the babies to regain their birth weight.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Assessment of Feeding Cues
Description
At 33 weeks corrected gestational age; a speech therapist will assess feeding cues daily using an objective oral feeding assessment tool
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
31 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Neonates between the gestational ages of 28 weeks and 32 weeks and 6 days
Parents ≥18 years of age
English speaking parents
Breastmilk as intended primary form of nutrition
Exclusion Criteria:
Congenital anomalies affecting hearing or feeding skills
Patients requiring HFOV or HFJV
Facility Information:
Facility Name
Christiana Care Health System
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Music and Feeding in NICU
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