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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Prematurity, Extreme Prematurity

Intervention / Treatment
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* Device: nfant(R) feeding system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Weeks
Maximum Age: 29 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective case matched controlled study (not a cohort). Enrolled infants will be matched with infants in the National Medical Index based on gestational age, gender, weight and comorbidities. A two cohort, mixed regression model would be used to correlate nfant® metrics to clinical outcomes.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nfant(R) feeding system<br>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<br>* 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<br>|

What is the study measuring?
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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 |