Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Extreme Prematurity
  • Prematurity
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention 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)Primary Purpose: Supportive Care

Participation Requirements

Age
Younger than 2229 years
Gender
Both males and females

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, Sl...

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.

Tracking Information

NCT #
NCT04256889
Collaborators
NFANT Labs
Investigators
Principal Investigator: Nanette Gremillion, PT, MS, CNT Woman's Hospital, Louisiana
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