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

NCT ID: NCT04256889

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-15
• Study Completion Date: 2024-03-13

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.

Conditions

Prematurity; Extreme Prematurity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

nfant(R) feeding system

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 22 Weeks
• Maximum Eligible Age: 29 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NFANT Labs

UNKNOWN

Sponsor Role: collaborator

Woman's

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nanette Gremillion, PT, MS, CNT

Role: PRINCIPAL_INVESTIGATOR

Woman's Hospital, Louisiana

Locations

Woman's Hospital

Baton Rouge, Louisiana, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

RP-19-013

Identifier Type: -

Identifier Source: org_study_id