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

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.

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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