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

Primary Purpose

Prematurity, Extreme Prematurity

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

nfant(R) feeding system

About this trial

This is an interventional supportive care trial for Prematurity

Eligibility Criteria

22 Weeks - 29 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Woman's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

nfant(R) feeding system

Arm Description

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.

Outcomes

Primary Outcome Measures

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

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

Number of participants with hospital readmission for feeding related issues

Phone Follow-up

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

Swallow Studies

Number of participants with increased Sucking Efficiency

nfant(R) feeding metrics

Number of participants with increased Sucking Amplitude

nfant(R) feeding metrics

Number of participants with increased Sucking Frequency

nfant(R) feeding metrics

Number of participants with increased Sucking Duration

nfant(R) feeding metrics

Number of participants with increased Sucking Smoothness

nfant(R) feeding metrics

Secondary Outcome Measures

Full Information

NCT ID

NCT04256889

First Posted

January 21, 2020

Last Updated

May 3, 2023

Sponsor

Woman's

Collaborators

NFANT Labs

1. Study Identification

Unique Protocol Identification Number

NCT04256889

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 15, 2020 (Actual)

Primary Completion Date

August 14, 2023 (Anticipated)

Study Completion Date

August 14, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Woman's

Collaborators

NFANT Labs

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prematurity, Extreme Prematurity

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

nfant(R) feeding system

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

nfant(R) feeding system

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of participants with decreased Feeding Related Length of Stay

Description

Starts when an infant can take 5 ml of breast milk or formula orally with autonomic stability

Time Frame

up to 48 hours

Title

Number of participants with Full oral feeding

Description

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

Title

Number of participants with hospital readmission for feeding related issues

Description

Phone Follow-up

Time Frame

Within the first 21 days after Neonatal Intensive Care Unit discharge

Title

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

Description

Swallow Studies

Time Frame

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

Title

Number of participants with increased Sucking Efficiency

Description

nfant(R) feeding metrics

Time Frame