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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-03

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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

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Breastfeeding

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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FEEDBACK system

Mother / infant dyad will use the FEEDBACK system during a breastfeeding session.

Group Type EXPERIMENTAL

FEEDBACK System

Intervention Type DEVICE

Smart Nipple Shield and Monitor Unit

Interventions

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FEEDBACK System

Smart Nipple Shield and Monitor Unit

Intervention Type DEVICE

Eligibility Criteria

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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.

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes