- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02919358
Music and Feeding in NICU
May 15, 2018 updated by: Christiana Care Health Services
The Mozart Effect and the Assessment of Weight Gain and Development of Feeding Skills in the NICU.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Delaware
-
Newark, Delaware, United States, 19713
- Christiana Care Health System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 7 months (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Music
Exposure to music, twice per day for the study period
|
|
OTHER: Control
No intervention; standard care.
|
This is the control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The primary outcome is time to regain birth weight
Time Frame: 2 weeks
|
We will track weight gain and will monitor how long it takes for the babies to regain their birth weight.
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of Feeding Cues
Time Frame: 2 weeks
|
At 33 weeks corrected gestational age; a speech therapist will assess feeding cues daily using an objective oral feeding assessment tool
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 1, 2016
Primary Completion (ACTUAL)
April 1, 2018
Study Completion (ACTUAL)
May 1, 2018
Study Registration Dates
First Submitted
September 27, 2016
First Submitted That Met QC Criteria
September 27, 2016
First Posted (ESTIMATE)
September 29, 2016
Study Record Updates
Last Update Posted (ACTUAL)
May 16, 2018
Last Update Submitted That Met QC Criteria
May 15, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DDD603441
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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