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

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04531566
• Other study ID #: HSC-MS-20-0741
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: Ashley N Morin, MD
• Phone: (713) 500-5800
• Email: Ashley.N.Morin[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 32 Weeks and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PMA at hospital discharge		up to 6 months after admission
Secondary	PMA at completion of first oral feed		1 month after enrollment.
Secondary	length of hospitalization		up to 6 months after admission
Secondary	number of gastrostomy tube		up to 6 months after admission
Secondary	oxygen at discharge		up to 6 months after admission
Secondary	safety outcomes during the feed as measured by the number of desaturations		2 months after enrollment
Secondary	safety outcomes during the feed as measured by the number of apnea episodes		2 months after enrollment
Secondary	safety outcomes during the feed as measured by the number of bradycardia episodes		2 months after enrollment
Secondary	safety outcomes as measured by the increase in fraction of inspired oxygen (FiO2) during and after feed		2 months after enrollment
Secondary	safety outcomes as measured by the increase in flow after feed		2 months after enrollment
Secondary	safety outcomes as measured by the number of choking episodes		2 months after enrollment
Secondary	safety outcomes as measured by the number of episodes of aspiration pneumonia		2 months after enrollment