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

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.

Study Overview

• Status: Suspended
• Conditions: Breastfeeding
• Intervention / Treatment: Device: FEEDBACK System

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 8 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FEEDBACK system; Mother / infant dyad will use the FEEDBACK system during a breastfeeding session.	Device: FEEDBACK System; Smart Nipple Shield and Monitor Unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	2 weeks per mother / infant dyad; 5 feedings

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	2 weeks, (prior to feeding session 1 and after feeding session 5) for each mother/infant dyad

Collaborators and Investigators

• Sponsor: Molex Ventures LLC
• Collaborators: University of Virginia
• Investigators: Principal Investigator: Brooke Vergales, MD, University of Virginia, Division of Neonatology, Department of Pediatrics

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2018
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: October 2, 2018
• First Submitted That Met QC Criteria: October 8, 2018
• First Posted (Actual): October 11, 2018

Study Record Updates

• Last Update Posted (Actual): January 7, 2020
• Last Update Submitted That Met QC Criteria: January 3, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: breastfeeding, pre-term infant, NICU
• Other Study ID Numbers: Prot-01-UVA rev 3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No