BreastfeedingNCT03702686
Pilot Study of the FEEDBACK System for Use With Infants in the Neonatal Intensive Care Unit at University of Virginia
A study testing FEEDBACK System in people with Breastfeeding, run by Molex Ventures LLC at 1 site in United States.
Trial summary
The purpose of this study is to assess the accuracy of FEEDBACK for measuring breastmilk intake of a pre-term baby. Mothers and babies will use the FEEDBACK system during a breastfeeding session in the NICU. Babies will be weighed prior to breastfeeding and again after breastfeeding. Read more about this study
- Who is it for?
- Ages Up to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- FEEDBACK System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2018to Dec 2020
- 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 Up to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Mother willing and able to provide informed consent for herself and her infant to participate in the study
- Mother / infant dyad has an indication for and is currently using a nipple shield as per Licensed Independent Practitioner (LIP) or UVA lactation consultant assessment and recommendation.
- FEEDBACK Smart Nipple Shield 'fit' assessment has been done by a study team member. Size to be comparable to the Smart Nipple Shield sizes (20mm or 24mm)
- Infant is <37 weeks corrected gestational age at time of first planned FEEDBACK feed and in the NICU
- Infant must be medically cleared for PO feeding as determined by presence of a milestone feeding order documented in EPIC.
- Mother willing to be present for PO feeding sessions per study requirements.
Who cannot join
- Infant with an oral, pharyngeal or mandibular abnormality where the use of a nipple shield would be contraindicated.
- Mother / infant dyad deemed ineligible based on LIP or lactation consultant assessment.
- Mother's with multiples > than 2. For example, if mother has triplets only 2 of the 3 infants are allowed to be in the study.
- Infant on any isolation precautions.
- Infant receiving any IV fluids.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Pilot Study of the FEEDBACK System for Use With Infants in the Neonatal Intensive Care Unit (NICU) at the University of Virginia (UVA)
The purpose of this study is to assess the accuracy of FEEDBACK for measuring breastmilk intake of a pre-term baby. Mothers and babies will use the FEEDBACK system during a breastfeeding session in the NICU. Babies will be weighed prior to breastfeeding and again after breastfeeding. The weight gain of the baby will be compared to the volume measured using FEEDBACK. The study will also evaluate the device safety and ease of use.
Read the detailed description
Researchers have long stated that accurate assessment of infant milk intake while breastfeeding is needed for clinical practice and research. Many methods for measuring milk intake have been studied. While the intake of formula fed infants can be directly measured based on the amount of fluid in the bottle, determining the actual milk intake for breastfed infants is more difficult. Precise feed volumes are especially important for infants in the NICU. Most premature infants are unable to breastfeed because they are not able to coordinate suckling and swallowing.
The FEEDBACK system includes a nipple shield and a monitoring unit. It helps protect the nipple of a breastfeeding mother as well as measures and displays the volume of milk, in mL or oz, that an infant consumes during a breast feeding session. Based on this information, a mother has quantitative data regarding her infant's milk intake for her own use or to share with her health care provider.
This study is designed in two phases. First, data will be collected from breastfeeding mothers of pre-term infants to develop an algorithm that can identify feeding patterns in the pre-term infant. Once established, accuracy of FEEDBACK will be assessed comparing pre and post weights of the breastfed infant to the volume intake measured by FEEDBACK.
- Conditions
- Breastfeeding
- Being tested
- FEEDBACK System
- Keywords
- breastfeeding, pre-term infant, NICU
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEEDBACK SystemDevice
Smart Nipple Shield and Monitor Unit
| Study group | Role | What they receive |
|---|---|---|
| FEEDBACK system | Experimental | Mother / infant dyad will use the FEEDBACK system during a breastfeeding session. Receives: Device: FEEDBACK System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of pre and post test weights (grams) during a breastfeeding session compared to the volume calculated by the FEEDBACK system.
The weight of the pre-term infant will be measured (grams) before and after breastfeeding. During the feeding the FEEDBACK system records digital signals which are used to calculate flow rate and volume. The weight gain (grams) will then be compared to the volume calculated by FEEDBACK to develop the algorithm.
Measured: 3 weeks per mother / infant dyad; up to 5 feedings
Accuracy (in grams) of the FEEDBACK system, based on comparison of the pre and post breastfeeding test weights to the calculated FEEDBACK volume.
The weight of the pre-term infant will be measured (grams) before and after breastfeeding. The weight gain will be compared to the FEEDBACK volume to calculate accuracy.
Measured: 2 weeks per mother / infant dyad; 5 feedings
Secondary outcomes (2)
Measure the Device Ease of Use via a questionnaire
Measure the mother's ease of use for the the FEEDBACK system based on a series of questions with a score of 1 - 5. (1 = difficult, 5 = easy)
Measured: 2 weeks, (after feeding session 5) for each mother/infant dyad
Measure the Mother's Perception of Breastfeeding via a questionnaire
Measure the mother's perception of breastfeeding based on a series of questions with a score of 1 - 5 (1 = difficult, 5 = easy) (Pilot Phase)
Measured: 2 weeks, (prior to feeding session 1 and after feeding session 5) for each mother/infant dyad
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start3 Oct 2018
- Primary completionOct 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: evaluating feasibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Molex Ventures LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Virginia
- Responsible party
- Sponsor
- Investigators
- Brooke Vergales, MD, Principal investigator, University of Virginia, Division of Neonatology, Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702686
- Sponsor's protocol ID
- Prot-01-UVA rev 3
- Status last verified
- Jan 2020
- First submitted
- 2 Oct 2018
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the FEEDBACK System for Use With Infants in the Neonatal Intensive Care Unit (NICU) at the University of Virginia (UVA)
- ClinicalTrials.gov ID
- NCT03702686
- Acronym / sponsor ID
- Prot-01-UVA rev 3
- Conditions
- Breastfeeding
- Keywords
- breastfeeding, pre-term infant, NICU
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: evaluating feasibility
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Molex Ventures LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Virginia
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 11 Oct 2018 (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 purpose of this study is to assess the accuracy of FEEDBACK for measuring breastmilk intake of a pre-term baby. Mothers and babies will use the FEEDBACK system during a breastfeeding session in the NICU. Babies will be weighed prior to breastfeeding and again after breastfeeding. The weight gain of the baby will be compared to the volume measured using FEEDBACK. The study will also evaluate the device safety and ease of use.
Detailed description
Researchers have long stated that accurate assessment of infant milk intake while breastfeeding is needed for clinical practice and research. Many methods for measuring milk intake have been studied. While the intake of formula fed infants can be directly measured based on the amount of fluid in the bottle, determining the actual milk intake for breastfed infants is more difficult. Precise feed volumes are especially important for infants in the NICU. Most premature infants are unable to breastfeed because they are not able to coordinate suckling and swallowing.
The FEEDBACK system includes a nipple shield and a monitoring unit. It helps protect the nipple of a breastfeeding mother as well as measures and displays the volume of milk, in mL or oz, that an infant consumes during a breast feeding session. Based on this information, a mother has quantitative data regarding her infant's milk intake for her own use or to share with her health care provider.
This study is designed in two phases. First, data will be collected from breastfeeding mothers of pre-term infants to develop an algorithm that can identify feeding patterns in the pre-term infant. Once established, accuracy of FEEDBACK will be assessed comparing pre and post weights of the breastfed infant to the volume intake measured by FEEDBACK.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FEEDBACK system | Experimental | Device: FEEDBACK SystemMother / infant dyad will use the FEEDBACK system during a breastfeeding session. |
Who may qualify
- Ages
- Up to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Mother willing and able to provide informed consent for herself and her infant to participate in the study
- Mother / infant dyad has an indication for and is currently using a nipple shield as per Licensed Independent Practitioner (LIP) or UVA lactation consultant assessment and recommendation.
- FEEDBACK Smart Nipple Shield 'fit' assessment has been done by a study team member. Size to be comparable to the Smart Nipple Shield sizes (20mm or 24mm)
- Infant is <37 weeks corrected gestational age at time of first planned FEEDBACK feed and in the NICU
- Infant must be medically cleared for PO feeding as determined by presence of a milestone feeding order documented in EPIC.
Key exclusion criteria (5 listed)
- Infant with an oral, pharyngeal or mandibular abnormality where the use of a nipple shield would be contraindicated.
- Mother / infant dyad deemed ineligible based on LIP or lactation consultant assessment.
- Mother's with multiples > than 2. For example, if mother has triplets only 2 of the 3 infants are allowed to be in the study.
- Infant on any isolation precautions.
- Infant receiving any IV fluids.
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 |
|---|---|---|
| FEEDBACK SystemSmart Nipple Shield and Monitor Unit | Device | FEEDBACK system |
Primary outcome
Measurement of pre and post test weights (grams) during a breastfeeding session compared to the volume calculated by the FEEDBACK system.
Time frame: 3 weeks per mother / infant dyad; up to 5 feedings
The weight of the pre-term infant will be measured (grams) before and after breastfeeding. During the feeding the FEEDBACK system records digital signals which are used to calculate flow rate and volume. The weight gain (grams) will then be compared to the volume calculated by FEEDBACK to develop the algorithm.
Accuracy (in grams) of the FEEDBACK system, based on comparison of the pre and post breastfeeding test weights to the calculated FEEDBACK volume.
Time frame: 2 weeks per mother / infant dyad; 5 feedings
The weight of the pre-term infant will be measured (grams) before and after breastfeeding. The weight gain will be compared to the FEEDBACK volume to calculate accuracy.
2 secondary outcomes
Measure the Device Ease of Use via a questionnaire
Time frame: 2 weeks, (after feeding session 5) for each mother/infant dyad
Measure the Mother's Perception of Breastfeeding via a questionnaire
Time frame: 2 weeks, (prior to feeding session 1 and after feeding session 5) for each mother/infant dyad
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
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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.
Brooke Vergales, MD principal investigator
University of Virginia, Division of Neonatology, Department of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FEEDBACK System in people with Breastfeeding, run by Molex Ventures LLC 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 6 inclusion and 5 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: paused, as of the sponsor's last update on 7 Jan 2020. 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?
Results are not available in the source record.
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?
Measurement of pre and post test weights (grams) during a breastfeeding session compared to the volume calculated by the FEEDBACK system. (time frame: 3 weeks per mother / infant dyad; up to 5 feedings). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2020; AzTrials last refreshed its copy on 30 Oct 2026.