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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03957941
Other study ID # 1370355
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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