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Effect of Music on Breastmilk

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ClinicalTrials.gov Identifier: NCT01893047
Recruitment Status : Completed
First Posted : July 8, 2013
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
Carl D'Angio, University of Rochester

Brief Summary:
A mother of a preterm infant listening to music while pumping her breasts will produce more milk than a similar mother who is not listening to music. A mother listening to live music will produce more milk than a mother listening to recorded music

Condition or disease Intervention/treatment Phase
Breast Milk Production Behavioral: live music Behavioral: recorded music Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of Quiet or Listening to Music While Breastfeeding on the Production and Lipid and Sodium Content of the Milk
Study Start Date : July 2013
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Arm Intervention/treatment
No Intervention: no music
The mother will be randomized to receive each od three experimental conditions: live music, recorded music, no music in random order over the course of three pumping sessions. She will then experience all three conditions again in random order
Experimental: live music
The mother will be randomized to receive each od three experimental conditions: live music, recorded music, no music in random order over the course of three pumping sessions. She will then experience all three conditions again in random order
Behavioral: live music
live harp music

Experimental: recorded music
The mother will be randomized to receive each od three experimental conditions: live music, recorded music, no music in random order over the course of three pumping sessions. She will then experience all three conditions again in random order
Behavioral: recorded music
recorded harp music




Primary Outcome Measures :
  1. Volume of milk in ten minutes [ Time Frame: 10 days ]
    Milk volume in Ml.


Secondary Outcome Measures :
  1. Milk sodium [ Time Frame: 10 days ]
    Sodium in Meq/L.

  2. Milk lipid [ Time Frame: 10 days ]
    Milk triglycerides and cholesterol in Mg/dl



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • First time mothers between the ages of 18 and 45 who have had a vaginal or caesarean delivery and are feeling well.
  • First time mothers are used to avoid confounding variables due to previous positive or negative experiences from expressing milk. Their infant will have been born at less than 32.0 weeks of gestation.
  • Mothers will intend to breastfeed and are planning to pump milk on site in the NICU at least once/day and will be recruited 7-10 days postpartum.
  • Mothers who smoke, are taking medication that may interfere with breastfeeding, and who have undergone prior breast surgery will not be excluded since they are their own control.
  • With regard to language, mothers must be able to understand the directions and sign a consent form in English.

Exclusion Criteria:

  • Mothers will not be recruited whose infant has a low likelihood of survival as determined by the attending physician.
  • Mothers who have been diagnosed with mastitis will not be recruited for the study.

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): NCT01893047


Locations
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United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
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Principal Investigator: Ruth Lawrence, MD University of Rochester

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Responsible Party: Carl D'Angio, Professor, Department of Pediatrics, Neonatology, University of Rochester
ClinicalTrials.gov Identifier: NCT01893047     History of Changes
Other Study ID Numbers: 47585
University of Rochester ( Other Identifier: University of Rochester )
First Posted: July 8, 2013    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Keywords provided by Carl D'Angio, University of Rochester:
breast milk production