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)

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.

Study Overview

• Status: Completed
• Conditions: Prematurity; Extreme Prematurity
• Intervention / Treatment: Device: nfant(R) feeding system

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70817
      • Woman's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 2 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Infants less than or equal to 29 6/7 weeks gestation at birth

Exclusion Criteria:

• Infants 30 weeks or greater gestation at birth
• Infants with known or suspected congenital anomalies or chromosomal abnormalities
• Infants with diagnoses known to interfere with oral feeding, including, but not limited to cleft lip. cleft palate, gastroschisis, Tracheoesophageal fistula, micrognathia.
• History of Intraventricular hemorrhage Grade 3 or 4 or Periventricular Leukomalacia
• Infants with known diagnoses known to interfere with Gastrointestinal absorption, including, but not limited to, Necrotizing Enterocolitis requiring surgical intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• 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: nfant(R) feeding system; Addition of nfant(R) technology, along with visual assessments and cue-based feeding practices, to facilitate an infant's progression to full oral feeding and potentially improve developmentally supportive feeding practices.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with decreased Feeding Related Length of Stay	Starts when an infant can take 5 ml of breast milk or formula orally with autonomic stability	up to 48 hours
Number of participants with Full oral feeding	Gestational age at which the infant first completes 90% of minimal ordered volumes without requiring gavage feeds for a 24 hour period	33 weeks through study completion, an average of 1 year
Number of participants with hospital readmission for feeding related issues	Phone Follow-up	Within the first 21 days after Neonatal Intensive Care Unit discharge
Number of inpatient Modified Barium Swallow Study (MBSS)/repeat MBSS	Swallow Studies	Neonatal Intensive Care Unit admit through study completion, an average of 1 year
Number of participants with increased Sucking Efficiency	nfant(R) feeding metrics	31 weeks GA through study completion, an average of 1 year
Number of participants with increased Sucking Amplitude	nfant(R) feeding metrics	31 weeks GA through study completion, an average of 1 year
Number of participants with increased Sucking Frequency	nfant(R) feeding metrics	31 weeks GA through study completion, an average of 1 year
Number of participants with increased Sucking Duration	nfant(R) feeding metrics	31 weeks GA through study completion, an average of 1 year
Number of participants with increased Sucking Smoothness	nfant(R) feeding metrics	31 weeks GA through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Woman's
• Collaborators: NFANT Labs
• Investigators: Principal Investigator: Nanette Gremillion, PT, MS, CNT, Woman's Hospital, Louisiana

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Actual): March 13, 2024
• Study Completion (Actual): March 13, 2024

Study Registration Dates

• First Submitted: January 21, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: RP-19-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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