Clinical trial NCT04531566: Preterm Functional Early Enteral Development (FEED) Trial on Respiratory Support
Official title: Preterm Functional Early Enteral Development (FEED) Trial on Respiratory Support
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premature Birth
Keywords: Prematurity
Oral Skills
Nasal CPAP oral feeds
HFNC oral feeds
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 50
Sex: ALL
Minimum age (years): 32
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Post menstrual Age (PMA) once full oral feeds are achieved as documented by not requiring gavage tube feeds for at least 24 hours
timeFrame: 2 months after enrollment
Secondary outcomes:
measure: PMA at hospital discharge
timeFrame: up to 6 months after admission
measure: PMA at completion of first oral feed
timeFrame: 1 month after enrollment.
measure: length of hospitalization
timeFrame: up to 6 months after admission
measure: number of gastrostomy tube
timeFrame: up to 6 months after admission
measure: oxygen at discharge
timeFrame: up to 6 months after admission
measure: safety outcomes during the feed as measured by the number of desaturations
timeFrame: 2 months after enrollment
measure: safety outcomes during the feed as measured by the number of apnea episodes
timeFrame: 2 months after enrollment
measure: safety outcomes during the feed as measured by the number of bradycardia episodes
timeFrame: 2 months after enrollment
measure: safety outcomes as measured by the increase in fraction of inspired oxygen (FiO2) during and after feed
timeFrame: 2 months after enrollment
measure: safety outcomes as measured by the increase in flow after feed
timeFrame: 2 months after enrollment
measure: safety outcomes as measured by the number of choking episodes
timeFrame: 2 months after enrollment
measure: safety outcomes as measured by the number of episodes of aspiration pneumonia
timeFrame: 2 months after enrollment
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Ashley N Morin, MD
role: PRINCIPAL_INVESTIGATOR
References: