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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04531566
Other study ID # HSC-MS-20-0741
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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