FamilyLink and Breastfeeding

NCT03957941 | Completed

• 1 other identifier: 1370355
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Pumping Efficiency

  Three times per day for two days

• FamilyLink breast milk fat content

  One day

• Standard breast milk fat content

  One day

• FamilyLink breast milk protein content

  One day

• Standard breast milk protein content

  One day

Study Arms (2)

FamilyLink Pumping

EXPERIMENTAL

Pump three times while away from infant, while watching baby via FamilyLink.

Behavioral: FamilyLink Pumping

Standard Pumping

ACTIVE COMPARATOR

Pump three times while away from infant, not watching baby via FamilyLink.

Behavioral: Standard Pumping

Interventions

FamilyLink Pumping BEHAVIORAL

Viewing baby via FamilyLink while pumping

FamilyLink Pumping

Standard Pumping BEHAVIORAL

Not viewing baby via FamilyLink while pumping

Standard Pumping

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California-Davis

Sacramento, California, 95817, United States

Location

Related Publications (1)

• 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.

  PMID: 35605051 DERIVED

Related Links

• Learn more or sign up for the study here!

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Laura Kair, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator and outcomes assessor will be blinded to the order the mothers were randomized to.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 21, 2019
• Study Start: September 26, 2019
• Primary Completion: May 27, 2022
• Study Completion: June 30, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)