FamilyLink and Breastfeeding

Breastfeeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03957941
• Other study ID #: 1370355
• Status: Completed
• Phase: N/A
• Start date: September 26, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 30, 2022
• Est. primary completion date: May 27, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Behavioral:
• FamilyLink Pumping
Viewing baby via FamilyLink while pumping
• Standard Pumping
Not viewing baby via FamilyLink while pumping

Locations

Country	Name	City	State
United States	University of California-Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Learn more or sign up for the study here!