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FamilyLink and Breastfeeding

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03957941
Enrollment
39
Registered
2019-05-21
Start date
2019-09-26
Completion date
2022-06-30
Last updated
2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding

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.

Interventions

BEHAVIORALFamilyLink Pumping

Viewing baby via FamilyLink while pumping

BEHAVIORALStandard Pumping

Not viewing baby via FamilyLink while pumping

Sponsors

University of California, Davis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

The investigator and outcomes assessor will be blinded to the order the mothers were randomized to.

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.

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean volume of Breast MilkTwo daysDifference in the the mean volume of breast milk expressed between intervention pumping sessions and control pumping sessions

Secondary

MeasureTime frameDescription
FamilyLink breast milk fat contentOne dayBreast 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
Standard breast milk fat contentOne dayBreast 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
FamilyLink breast milk protein contentOne dayBreast 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
Standard breast milk protein contentOne dayBreast 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
Pumping EfficiencyThree times per day for two daysPumping Efficiency will be calculated using the volume of breast milk expressed divided by the number of minutes of the pumping session
Standard breast milk carbohydrate contentOne dayBreast 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
Quantitative pumping experienceThree times per day for two daysBreast 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)
Qualitative pumping experienceTwo daysMothers 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.
FamilyLink breast milk carbohydrate contentOne dayBreast 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026