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

  • STATUS
    Recruiting
  • participants needed
    50
  • sponsor
    Woman's
Updated on 19 February 2024
prematurity
premature birth

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.

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.

Details
Condition Prematurity, Extreme Prematurity
Age 1-1 years
Treatment nfant(R) feeding system
Clinical Study IdentifierNCT04256889
SponsorWoman's
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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