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OpenTrials
Completed

NCT Number: NCT03957941

FamilyLink and Breastfeeding

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.

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California-Davis

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FamilyLink Pumping

Behavioral

Viewing baby via FamilyLink while pumping

Standard Pumping

Behavioral

Not viewing baby via FamilyLink while pumping

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Impact of Visual Contact With the Premature Infant on Maternal Breast Milk Expression

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 21, 2019
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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