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

Study Overview
=================
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.

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

Conditions
-----------------
Premature Birth

Intervention / Treatment
-----------------
* Dietary Supplement: Oral Feed
* Dietary Supplement: Usual care


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 32 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Feed Intervention Group<br> | Dietary Supplement: Oral Feed<br>* 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.<br>|
| Active Comparator: Usual care<br> | Dietary Supplement: Usual care<br>* Infants will not start oral feeds until on HFNC 2 Litres or less. Oral feeds will be started on the discretion of the physician.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| safety outcomes during the feed as measured by the number of desaturations |  | 2 months after enrollment | 
| safety outcomes during the feed as measured by the number of apnea episodes |  | 2 months after enrollment | 
| safety outcomes during the feed as measured by the number of bradycardia episodes |  | 2 months after enrollment | 
| safety outcomes as measured by the increase in fraction of inspired oxygen (FiO2) during and after feed |  | 2 months after enrollment | 
| safety outcomes as measured by the increase in flow after feed |  | 2 months after enrollment | 
| safety outcomes as measured by the number of choking episodes |  | 2 months after enrollment | 
| safety outcomes as measured by the number of episodes of aspiration pneumonia |  | 2 months after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prematurity, Oral Skills, Nasal CPAP oral feeds, HFNC oral feeds