NCT03702686

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)

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Molex Ventures LLC · Industry
• Sex: All
• Age: 37 Weeks
• Healthy volunteers: Accepted

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.

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.

Conditions

• Breastfeeding

Interventions

Type	Name	Description
DEVICE	FEEDBACK System	Smart Nipple Shield and Monitor Unit

Timeline

• Start date: 2018-10-03
• Primary completion: 2020-10-01
• Completion: 2020-12-01
• First posted: 2018-10-11
• Last updated: 2020-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study