Pilot Study of the FEEDBACK System for Use With Infants in the Neonatal Intensive Care Unit at University of Virginia

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.

Inclusion Criteria:

1. Mother willing and able to provide informed consent for herself and her infant to
participate in the study

2. 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.

3. 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)

4. Infant is <37 weeks corrected gestational age at time of first planned FEEDBACK feed
and in the NICU

5. Infant must be medically cleared for PO feeding as determined by presence of a
milestone feeding order documented in EPIC.

6. Mother willing to be present for PO feeding sessions per study requirements.

Exclusion Criteria:

1. Infant with an oral, pharyngeal or mandibular abnormality where the use of a nipple
shield would be contraindicated.

2. Mother / infant dyad deemed ineligible based on LIP or lactation consultant
assessment.

3. 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.

4. Infant on any isolation precautions.

5. Infant receiving any IV fluids.