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

Woman's

Status: Completed

Conditions: Prematurity; Extreme Prematurity

Treatments: Device: nfant(R) feeding system

Study type: Interventional

Funder types: Other

Identifiers

NCT04256889

RP-19-013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 22 to 29 weeks old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

nfant(R) feeding system

Experimental group

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.

Treatment:

Device: nfant(R) feeding system