Preterm Functional Early Enteral Development (FEED) Trial on Respiratory Support

The University of Texas Health Science Center, Houston1 site in 1 country50 target enrollmentOctober 20, 2020

ConditionsPremature Birth

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Premature Birth
Sponsor: The University of Texas Health Science Center, Houston
Enrollment: 50
Locations: 1
Primary Endpoint: Post menstrual Age (PMA) once full oral feeds are achieved as documented by not requiring gavage tube feeds for at least 24 hours
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to demonstrate that allowing infants that require high flow nasal cannula (HFNC)/Continuous positive airway pressure (CPAP) to orally feed if demonstrating oral cues will achieve full oral feeds faster.

Registry

clinicaltrials.gov

Start Date

October 20, 2020

End Date

December 31, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The University of Texas Health Science Center, Houston

Responsible Party

Principal Investigator

Ashley N Morin

Fellow

The University of Texas Health Science Center, Houston

Eligibility Criteria

Inclusion Criteria

•infants that require greater than 2 litres per minute (LPM) high flow nasal canula or CPAP with a max setting of 6cm H20 FiO2 30% or less for at least 72 hours or more
•Tolerating enteral feeds of 120 ml/kg/day

Exclusion Criteria

•Major congenital anomalies (pulmonary malformations, airway malformations, craniofacial defects, major congenital heart disease, combined pulmonary intestinal malformations)
•Metabolic disorder
•Major gastrointestinal surgeries
•Patent ductus arteriosus (PDA) ligation surgery
•Outborn deliveries greater than 7 days old

Outcomes

Primary Outcomes

Post menstrual Age (PMA) once full oral feeds are achieved as documented by not requiring gavage tube feeds for at least 24 hours

Time Frame: 2 months after enrollment

Measured in the electronic medical record

Secondary Outcomes

safety outcomes during the feed as measured by the number of bradycardia episodes(2 months after enrollment)
safety outcomes as measured by the increase in fraction of inspired oxygen (FiO2) during and after feed(2 months after enrollment)
PMA at hospital discharge(up to 6 months after admission)
length of hospitalization(up to 6 months after admission)
safety outcomes as measured by the increase in flow after feed(2 months after enrollment)
oxygen at discharge(up to 6 months after admission)
PMA at completion of first oral feed(1 month after enrollment.)
number of gastrostomy tube(up to 6 months after admission)
safety outcomes as measured by the number of choking episodes(2 months after enrollment)
safety outcomes as measured by the number of episodes of aspiration pneumonia(2 months after enrollment)
safety outcomes during the feed as measured by the number of desaturations(2 months after enrollment)
safety outcomes during the feed as measured by the number of apnea episodes(2 months after enrollment)