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

Not Applicable

• Conditions: Premature Birth
• Interventions: Dietary Supplement: Oral Feed; Dietary Supplement: Usual care

• Registration Number: NCT04531566
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-08-27
• Study First Posted: 2020-08-28
• Study Start: 2020-10-20
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-19
• Last Update Posted: 2022-05-23
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Feed Intervention Group	Oral Feed	-
Usual care	Usual care	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States