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

Woman's23 enrolled

Overview

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.

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

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Prematurity Extreme Prematurity

Interventions

nfant(R) feeding systemDEVICE

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

Eligibility

Sex: ALLMin age: 22 WeeksMax age: 29 Weeks

Medical Language ↔ Plain English

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

Locations (1)

Woman's Hospital

Baton Rouge, Louisiana, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 33 weeks through study completion, an average of 1 year

Number of participants with hospital readmission for feeding related issues

Phone Follow-up

Time frame: Within the first 21 days after Neonatal Intensive Care Unit discharge

Number of inpatient Modified Barium Swallow Study (MBSS)/repeat MBSS

Swallow Studies

Time frame: Neonatal Intensive Care Unit admit through study completion, an average of 1 year

Number of participants with increased Sucking Efficiency

nfant(R) feeding metrics

Time frame: 31 weeks GA through study completion, an average of 1 year

Number of participants with increased Sucking Amplitude

nfant(R) feeding metrics

Time frame: 31 weeks GA through study completion, an average of 1 year

Number of participants with increased Sucking Frequency

nfant(R) feeding metrics

Time frame: 31 weeks GA through study completion, an average of 1 year

Number of participants with increased Sucking Duration

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.