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

NCT03702686 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-01-07

No results posted yet for this study

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. 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.

Conditions

  • Breastfeeding

Interventions

DEVICE

FEEDBACK System

Smart Nipple Shield and Monitor Unit

Sponsors & Collaborators

  • University of Virginia

    collaborator OTHER

  • Molex Ventures LLC

    lead INDUSTRY

Principal Investigators

  • Brooke Vergales, MD · University of Virginia, Division of Neonatology, Department of Pediatrics

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
37 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-03
Primary Completion
2020-10-31
Completion
2020-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03702686 on ClinicalTrials.gov