FamilyLink and Breastfeeding

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

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.

Study Overview

• Status: Completed
• Conditions: Breastfeeding
• Intervention / Treatment: Behavioral: FamilyLink Pumping; Behavioral: Standard Pumping

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California-Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean volume of Breast Milk	Difference in the the mean volume of breast milk expressed between intervention pumping sessions and control pumping sessions	Two days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pumping Efficiency	Pumping Efficiency will be calculated using the volume of breast milk expressed divided by the number of minutes of the pumping session	Three times per day for two days
FamilyLink breast milk fat content	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	One day
Standard breast milk fat content	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	One day
FamilyLink breast milk protein content	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	One day
Standard breast milk protein content	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	One day
FamilyLink breast milk carbohydrate content	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	One day
Standard breast milk carbohydrate content	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	One day
Quantitative pumping experience	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)	Three times per day for two days
Qualitative pumping experience	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.	Two days

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Laura Kair, MD, University of California, Davis

Publications and helpful links

General Publications

• Hoyt-Austin AE, Miller IT, Kuhn-Riordon KM, Rosenthal JL, Chantry CJ, Marcin JP, Hoffman KR, Kair LR. Bonding, Relaxation, Separation, and Connection: Expressing Human Milk While Videoconferencing with the Hospitalized Premature Infant. Breastfeed Med. 2022 Aug;17(8):653-659. doi: 10.1089/bfm.2021.0214. Epub 2022 May 23.

Helpful Links

• Learn more or sign up for the study here!

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2019
• Primary Completion (Actual): May 27, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (Actual): May 21, 2019

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 1370355

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No