FamilyLink and Breastfeeding

Study Overview
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Brief Summary
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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.

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

Conditions
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Breastfeeding

Intervention / Treatment
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* Behavioral: FamilyLink Pumping
* Behavioral: Standard Pumping


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FamilyLink Pumping<br>Pump three times while away from infant, while watching baby via FamilyLink. | Behavioral: FamilyLink Pumping<br>* Viewing baby via FamilyLink while pumping<br>|
| Active Comparator: Standard Pumping<br>Pump three times while away from infant, not watching baby via FamilyLink. | Behavioral: Standard Pumping<br>* Not viewing baby via FamilyLink while pumping<br>|

What is the study measuring?
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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 |