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

NCT04531566 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-05-23

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Ashley N Morin, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-20
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04531566 on ClinicalTrials.gov