NCT03702686

Brief 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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

October 3, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 11, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

October 2, 2018

Last Update Submit

January 3, 2020

Conditions

Breastfeeding

Keywords

breastfeeding, pre-term infant, NICU

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Measure the Device Ease of Use via a questionnaire

    2 weeks, (after feeding session 5) for each mother/infant dyad

  • Measure the Mother's Perception of Breastfeeding via a questionnaire

    2 weeks, (prior to feeding session 1 and after feeding session 5) for each mother/infant dyad

Study Arms (1)

FEEDBACK system

EXPERIMENTAL

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

Device: FEEDBACK System

Interventions

FEEDBACK SystemDEVICE

Smart Nipple Shield and Monitor Unit

FEEDBACK system

Eligibility Criteria

AgeUp to 37 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Brooke Vergales, MD

    University of Virginia, Division of Neonatology, Department of Pediatrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2018

First Posted

October 11, 2018

Study Start

October 3, 2018

Primary Completion

October 1, 2020

Study Completion

December 1, 2020

Last Updated

January 7, 2020

Record last verified: 2020-01

Locations

US(1)