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

NCT ID: NCT04531566

Last Updated: 2022-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-20
• Study Completion Date: 2022-12-31

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.

Conditions

Premature Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral Feed Intervention Group

Group Type: EXPERIMENTAL

Oral Feed

Intervention Type: DIETARY_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 care

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: DIETARY_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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 32 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Ashley N Morin

Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashley N Morin, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ashley N Morin, MD

Role: CONTACT

Ashley.N.Morin@uth.tmc.edu

(713) 500-5800

Facility Contacts

Ashley N Morin, MD

Role: primary

Ashley.N.Morin@uth.tmc.edu

713-500-5800

Other Identifiers

HSC-MS-20-0741

Identifier Type: -

Identifier Source: org_study_id