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

Paused · Not applicable

Conditions studied: Breastfeeding

In brief

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.

Key facts

Study ID

NCT03702686

Run by

Molex Ventures LLC

People needed

40

Starts

2018-10-03

Expected to finish

2020-12-01

Last updated by the study team

2020-01-07

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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