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FamilyLink and Breastfeeding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03957941
Recruitment Status : Completed
First Posted : May 21, 2019
Last Update Posted : August 9, 2022
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
The central hypothesis guiding this project is that having mothers view live video of their babies while they are pumping increases milk volume, caloric density, and maternal pumping experience.

Condition or disease Intervention/treatment Phase
Breastfeeding Behavioral: FamilyLink Pumping Behavioral: Standard Pumping Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will be randomized to the order of Intervention and Control pumping session. Excluding the first pumping session of the day, as the volume is highest at that time and more consistent throughout the rest of the day. All 30 mothers will be asked to A (Control): Pump three times while they are away from their infant without using FamilyLink for video observation of their baby during pumping and B (Intervention): Pump three times while they are away from their infant, while watching their baby via FamilyLink.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The investigator and outcomes assessor will be blinded to the order the mothers were randomized to.
Primary Purpose: Health Services Research
Official Title: Impact of Visual Contact With the Premature Infant on Maternal Breast Milk Expression
Actual Study Start Date : September 26, 2019
Actual Primary Completion Date : May 27, 2022
Actual Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
Experimental: FamilyLink Pumping
Pump three times while away from infant, while watching baby via FamilyLink.
Behavioral: FamilyLink Pumping
Viewing baby via FamilyLink while pumping

Active Comparator: Standard Pumping
Pump three times while away from infant, not watching baby via FamilyLink.
Behavioral: Standard Pumping
Not viewing baby via FamilyLink while pumping




Primary Outcome Measures :
  1. Mean volume of Breast Milk [ Time Frame: Two days ]
    Difference in the the mean volume of breast milk expressed between intervention pumping sessions and control pumping sessions


Secondary Outcome Measures :
  1. Pumping Efficiency [ Time Frame: Three times per day for two days ]
    Pumping Efficiency will be calculated using the volume of breast milk expressed divided by the number of minutes of the pumping session

  2. FamilyLink breast milk fat content [ Time Frame: One day ]
    Breast milk fat content will be measured from a 5 ml sample of milk collected after a FamilyLink pumping session; The total weight and kilocalories/mL of each nutrient will be tested

  3. Standard breast milk fat content [ Time Frame: One day ]
    Breast milk fat content will be measured from a 5 ml sample of milk collected after a Standard pumping session; The total weight and kilocalories/mL of each nutrient will be tested

  4. FamilyLink breast milk protein content [ Time Frame: One day ]
    Breast milk protein content will be measured from a 5 ml sample of milk collected after a FamilyLink pumping session; The total weight and kilocalories/mL of each nutrient will be tested

  5. Standard breast milk protein content [ Time Frame: One day ]
    Breast milk protein content will be measured from a 5 ml sample of milk collected after a Standard pumping session; The total weight and kilocalories/mL of each nutrient will be tested

  6. FamilyLink breast milk carbohydrate content [ Time Frame: One day ]
    Breast milk carbohydrate content will be measured from a 5 ml sample of milk collected after a FamilyLink pumping session; The total weight and kilocalories/mL of each nutrient will be tested

  7. Standard breast milk carbohydrate content [ Time Frame: One day ]
    Breast milk carbohydrate content will be measured from a 5 ml sample of milk collected after a Standard pumping session; The total weight and kilocalories/mL of each nutrient will be tested

  8. Quantitative pumping experience [ Time Frame: Three times per day for two days ]
    Breast Milk Expression Experience Personal Experience Subscale; a five question subscale to measure participants experience with breastfeeding; the minimum score is 5 and the maximum score is 25 (higher scores indicate better outcomes)

  9. Qualitative pumping experience [ Time Frame: Two days ]
    Mothers will be asked open-ended questions, "How was your pumping experience?" "Please describe your experience watching your baby while pumping." "Would you want to use FamilyLink during pumping in the future? Why or why not?" and "Any suggestions to improve the FamilyLink pumping experience?" Responses to these items will be analyzed qualitatively.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mothers of 30 preterm infants (born before 34 weeks gestational age) admitted to the University of California, Davis neonatal intensive care unit (NICU)
  • Mother is pumping breastmilk
  • Delivery at least 7 days prior
  • Mother not an inpatient,

Exclusion Criteria:

  • Mother has HIV
  • Mother without access to a computer, smartphone, or tablet to access FamilyLink
  • Infant delivered via surrogacy
  • Maternal age outside limit of 18 to 50

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): NCT03957941


Locations
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United States, California
University of California-Davis
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Laura Kair, MD University of California, Davis
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03957941    
Other Study ID Numbers: 1370355
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: August 9, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No