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

Primary Purpose

Premature Birth

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Oral Feed

Usual care

About this trial

This is an interventional treatment trial for Premature Birth focused on measuring Prematurity, Oral Skills, Nasal CPAP oral feeds, HFNC oral feeds

Eligibility Criteria

32 Weeks - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oral Feed Intervention Group

Usual care

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

PMA at hospital discharge

PMA at completion of first oral feed

length of hospitalization

number of gastrostomy tube

oxygen at discharge

safety outcomes during the feed as measured by the number of desaturations

safety outcomes during the feed as measured by the number of apnea episodes

safety outcomes during the feed as measured by the number of bradycardia episodes

safety outcomes as measured by the increase in fraction of inspired oxygen (FiO2) during and after feed

safety outcomes as measured by the increase in flow after feed

safety outcomes as measured by the number of choking episodes

safety outcomes as measured by the number of episodes of aspiration pneumonia

Full Information

NCT ID

NCT04531566

First Posted

August 25, 2020

Last Updated

May 19, 2022

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT04531566

Brief Title

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

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 20, 2020 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Premature Birth

Keywords

Prematurity, Oral Skills, Nasal CPAP oral feeds, HFNC oral feeds

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Oral Feed Intervention Group

Arm Type

Experimental

Arm Title

Usual care

Arm Type

Active Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Oral Feed

Intervention Description

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

Intervention Name(s)

Usual care

Intervention Description

Infants will not start oral feeds until on HFNC 2 Litres or less. Oral feeds will be started on the discretion of the physician.

Primary Outcome Measure Information:

Title

Post menstrual Age (PMA) once full oral feeds are achieved as documented by not requiring gavage tube feeds for at least 24 hours

Description

Measured in the electronic medical record

Time Frame

2 months after enrollment

Secondary Outcome Measure Information:

Title

PMA at hospital discharge

Time Frame

up to 6 months after admission

Title

PMA at completion of first oral feed

Time Frame

1 month after enrollment.

Title

length of hospitalization

Time Frame

up to 6 months after admission

Title

number of gastrostomy tube

Time Frame

up to 6 months after admission

Title

oxygen at discharge

Time Frame

up to 6 months after admission

Title

safety outcomes during the feed as measured by the number of desaturations

Time Frame

2 months after enrollment

Title

safety outcomes during the feed as measured by the number of apnea episodes

Time Frame

2 months after enrollment

Title

safety outcomes during the feed as measured by the number of bradycardia episodes

Time Frame

2 months after enrollment

Title

safety outcomes as measured by the increase in fraction of inspired oxygen (FiO2) during and after feed

Time Frame

2 months after enrollment

Title

safety outcomes as measured by the increase in flow after feed

Time Frame

2 months after enrollment

Title

safety outcomes as measured by the number of choking episodes

Time Frame

2 months after enrollment

Title

safety outcomes as measured by the number of episodes of aspiration pneumonia

Time Frame

2 months after enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

32 Weeks

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ashley N Morin, MD

Phone

(713) 500-5800

Ashley.N.Morin@uth.tmc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ashley N Morin, MD

Organizational Affiliation

The University of Texas Health Science Center, Houston

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Texas Health Science Center at Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ashley N Morin, MD

Phone

713-500-5800

Ashley.N.Morin@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD

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

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