NCT04256889

Use Of Nfant(R) Technology Feeding System For Infants Less Than 30 Weeks GA

Use of Nfant(R) Technology Feeding System As An Adjunct To Visual Assessment And Cue-Based Feedings For Infants Born Less Than 30 Weeks Gestational Age (GA)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Woman's · Academic / Other
• Sex: All
• Age: 22 Weeks – 29 Weeks
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to utilize the objective data provided by the nfant® suite of products, along with current NICU visual assessment and cue-based feeding practices, in order to determine if feeding performance outcomes and clinical decision making for individualized feeding plans for premature infants born less than 30 weeks PMA are impacted.

Detailed description

Will obtain 5 official readings using the nfant(R) technology: baseline between 31 0/7 weeks and 32 0/7 weeks Post-Menstrual Age (PMA) with No Flow nipple, Cue-Based Feeding Readiness Reading with No Flow nipple no sooner than 33 0/7 weeks PMA, Post-Sequencing Reading with Extra Slow Flow nipple, Slow Flow nipple Reading, and Standard nipple Reading. The technology will also be utilized between readings 2 to 3 times a week. Phone Follow-up 2 question survey will be administered 21 days after discharge from Neonatal Intensive Care Unit.This survey entails routine questions regarding re-admission, to clarify if readmission was within 21 days of discharge, and if the reason for re-admission was feeding related.

Conditions

• Prematurity
• Extreme Prematurity

Interventions

Type	Name	Description
DEVICE	nfant(R) feeding system	Use of nfant(R) technology feeding system as an adjunct to visual assessment and cue-based feedings for infants born less than 30 weeks GA

Timeline

• Start date: 2020-01-15
• Primary completion: 2024-03-13
• Completion: 2024-03-13
• First posted: 2020-02-05
• Last updated: 2024-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study