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

The University of Texas Health Science Center, Houston50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Premature Birth

Interventions

Oral FeedDIETARY_SUPPLEMENT

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.

Usual careDIETARY_SUPPLEMENT

Infants will not start oral feeds until on HFNC 2 Litres or less. Oral feeds will be started on the discretion of the physician.

Eligibility

Sex: ALLMin age: 32 Weeks

Medical Language ↔ Plain English

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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

RECRUITING

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

Measured in the electronic medical record

Time frame: 2 months after enrollment

Secondary Outcomes

PMA at hospital discharge

Time frame: up to 6 months after admission

PMA at completion of first oral feed

Time frame: 1 month after enrollment.

length of hospitalization

Time frame: up to 6 months after admission

number of gastrostomy tube

Time frame: up to 6 months after admission

oxygen at discharge

Time frame: up to 6 months after admission

safety outcomes during the feed as measured by the number of desaturations

Time frame: 2 months after enrollment

safety outcomes during the feed as measured by the number of apnea episodes

Time frame: 2 months after enrollment

safety outcomes during the feed as measured by the number of bradycardia episodes

Time frame: 2 months after enrollment

safety outcomes as measured by the increase in fraction of inspired oxygen (FiO2) during and after feed

Time frame: 2 months after enrollment

Central Contacts

Ashley N Morin, MD

CONTACT

(713) 500-5800 Ashley.N.Morin@uth.tmc.edu

Data from ClinicalTrials.gov

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