BreastfeedingNCT03957941
FamilyLink and Breastfeeding
A study testing FamilyLink Pumping and Standard Pumping in people with Breastfeeding, run by University of California, Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breastfeeding
- What is being tested?
- FamilyLink Pumping and Standard Pumping
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2019to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California-Davis
Sacramento, California, 95817
About this study
Official title: 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.
- Conditions
- Breastfeeding
- Being tested
- FamilyLink Pumping, Standard Pumping
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FamilyLink PumpingBehavioural
Viewing baby via FamilyLink while pumping
Standard PumpingBehavioural
Not viewing baby via FamilyLink while pumping
| Study group | Role | What they receive |
|---|---|---|
| FamilyLink Pumping | Experimental | Pump three times while away from infant, while watching baby via FamilyLink. Receives: Behavioral: FamilyLink Pumping |
| Standard Pumping | Active comparator | Pump three times while away from infant, not watching baby via FamilyLink. Receives: Behavioral: Standard Pumping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean volume of Breast Milk
Difference in the the mean volume of breast milk expressed between intervention pumping sessions and control pumping sessions
Measured: Two days
Secondary outcomes (9)
Pumping Efficiency
Pumping Efficiency will be calculated using the volume of breast milk expressed divided by the number of minutes of the pumping session
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: Two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start26 Sep 2019
- Primary completion27 May 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Kair, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957941
- Sponsor's protocol ID
- 1370355
- Status last verified
- Aug 2022
- First submitted
- 13 May 2019
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35605051
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Visual Contact With the Premature Infant on Maternal Breast Milk Expression
- ClinicalTrials.gov ID
- NCT03957941
- Acronym / sponsor ID
- 1370355
- Conditions
- Breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| FamilyLink Pumping | Experimental | Behavioral: FamilyLink PumpingPump three times while away from infant, while watching baby via FamilyLink. |
| Standard Pumping | Active comparator | Behavioral: Standard PumpingPump three times while away from infant, not watching baby via FamilyLink. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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,
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FamilyLink PumpingViewing baby via FamilyLink while pumping | Behavioural | FamilyLink Pumping |
| Standard PumpingNot viewing baby via FamilyLink while pumping | Behavioural | Standard Pumping |
Primary outcome
Mean volume of Breast Milk
Time frame: Two days
Difference in the the mean volume of breast milk expressed between intervention pumping sessions and control pumping sessions
9 secondary outcomes
Pumping Efficiency
Time frame: Three times per day for two days
FamilyLink breast milk fat content
Time frame: One day
Standard breast milk fat content
Time frame: One day
FamilyLink breast milk protein content
Time frame: One day
Standard breast milk protein content
Time frame: One day
FamilyLink breast milk carbohydrate content
Time frame: One day
Standard breast milk carbohydrate content
Time frame: One day
Quantitative pumping experience
Time frame: Three times per day for two days
Qualitative pumping experience
Time frame: Two days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Derived from this study: PubMed 35605051Hoyt-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.
- Learn more or sign up for the study here!Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Kair, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FamilyLink Pumping and Standard Pumping in people with Breastfeeding, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean volume of Breast Milk (time frame: Two days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03957941, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.