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

Not Applicable

Completed

• Conditions: Extreme Prematurity; Prematurity

• Registration Number: NCT04256889
• Lead Sponsor: Woman's

Brief 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.

Study Timeline

• Study Start: 2020-01-15
• Study First Submitted: 2020-01-21
• Study First Submitted QC: 2020-02-04
• Study First Posted: 2020-02-05
• Status Verified: 2024-03
• Primary Completion: 2024-03-13
• Study Completion: 2024-03-13
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

Woman's Hospital; 🇺🇸 Baton Rouge, Louisiana, United States