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

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.

Study Overview

• Status: Recruiting
• Conditions: Premature Birth
• Intervention / Treatment: Dietary supplement: Oral Feed; Dietary supplement: Usual care

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashley N Morin, MD; Phone Number: (713) 500-5800; Email: Ashley.N.Morin@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Ashley N Morin, MD; Phone Number: 713-500-5800; Email: Ashley.N.Morin@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care	Dietary supplement: Usual care; Infants will not start oral feeds until on HFNC 2 Litres or less. Oral feeds will be started on the discretion of the physician.
Experimental: Oral Feed Intervention Group	Dietary supplement: Oral Feed; Infant will be seen by occupational therapist (OT) twice a week and assessed for oral cues. If infant shows oral cues then the occupational therapist will proceed with feeding strategies. Oral feeding strategies include pacifier dips, open nipple trials with syringe controlled bolus size (1-4mls) and po trials up to 10mls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post menstrual Age (PMA) once full oral feeds are achieved as documented by not requiring gavage tube feeds for at least 24 hours	Measured in the electronic medical record	2 months after enrollment

Secondary Outcome Measures

Outcome Measure	Time Frame
PMA at hospital discharge	up to 6 months after admission
PMA at completion of first oral feed	1 month after enrollment.
length of hospitalization	up to 6 months after admission
number of gastrostomy tube	up to 6 months after admission
oxygen at discharge	up to 6 months after admission
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
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
safety outcomes as measured by the increase in flow after feed	2 months after enrollment
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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Ashley N Morin, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Prematurity; Oral Skills; Nasal CPAP oral feeds; HFNC oral feeds
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: HSC-MS-20-0741

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No