Preterm Functional Early Enteral Development (FEED) Trial on Respiratory Support
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2020
CompletedFirst Posted
Study publicly available on registry
August 28, 2020
CompletedStudy Start
First participant enrolled
October 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMay 23, 2022
May 1, 2022
2.2 years
August 25, 2020
May 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
2 months after enrollment
Secondary Outcomes (12)
PMA at hospital discharge
up to 6 months after admission
PMA at completion of first oral feed
1 month after enrollment.
length of hospitalization
up to 6 months after admission
number of gastrostomy tube
up to 6 months after admission
oxygen at discharge
up to 6 months after admission
- +7 more secondary outcomes
Study Arms (2)
Oral Feed Intervention Group
EXPERIMENTALUsual care
ACTIVE COMPARATORInterventions
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.
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ashley N Morin, MD
The University of Texas Health Science Center, Houston
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Fellow
Study Record Dates
First Submitted
August 25, 2020
First Posted
August 28, 2020
Study Start
October 20, 2020
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
May 23, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share