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

The University of Texas System (UT)

Status: Unknown

Conditions: Premature Birth

Treatments: Dietary Supplement: Oral Feed; Dietary Supplement: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT04531566

HSC-MS-20-0741

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 32+ weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Oral Feed Intervention Group

Experimental group

Treatment:

Dietary Supplement: Oral Feed

Usual care

Active Comparator group

Treatment:

Dietary Supplement: Usual care