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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04531566
Recruitment Status : Recruiting
First Posted : August 28, 2020
Last Update Posted : November 6, 2020
Sponsor:
Information provided by (Responsible Party):
Ashley N Morin, The University of Texas Health Science Center, Houston

Study Description
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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.

Condition or disease Intervention/treatment Phase
Premature Birth Dietary Supplement: Oral Feed Dietary Supplement: Usual care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preterm Functional Early Enteral Development (FEED) Trial on Respiratory Support
Actual Study Start Date : October 20, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Oral Feed Intervention Group 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.
Active Comparator: Usual care Dietary Supplement: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Post menstrual Age (PMA) once full oral feeds are achieved as documented by not requiring gavage tube feeds for at least 24 hours [ Time Frame: 2 months after enrollment ]
    Measured in the electronic medical record


Secondary Outcome Measures :
  1. PMA at hospital discharge [ Time Frame: up to 6 months after admission ]
  2. PMA at completion of first oral feed [ Time Frame: 1 month after enrollment. ]
  3. length of hospitalization [ Time Frame: up to 6 months after admission ]
  4. number of gastrostomy tube [ Time Frame: up to 6 months after admission ]
  5. oxygen at discharge [ Time Frame: up to 6 months after admission ]
  6. safety outcomes during the feed as measured by the number of desaturations [ Time Frame: 2 months after enrollment ]
  7. safety outcomes during the feed as measured by the number of apnea episodes [ Time Frame: 2 months after enrollment ]
  8. safety outcomes during the feed as measured by the number of bradycardia episodes [ Time Frame: 2 months after enrollment ]
  9. safety outcomes as measured by the increase in fraction of inspired oxygen (FiO2) during and after feed [ Time Frame: 2 months after enrollment ]
  10. safety outcomes as measured by the increase in flow after feed [ Time Frame: 2 months after enrollment ]
  11. safety outcomes as measured by the number of choking episodes [ Time Frame: 2 months after enrollment ]
  12. safety outcomes as measured by the number of episodes of aspiration pneumonia [ Time Frame: 2 months after enrollment ]

Eligibility Criteria
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Ages Eligible for Study:   32 Weeks and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04531566


Contacts
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Contact: Ashley N Morin, MD (713) 500-5800 Ashley.N.Morin@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Ashley N Morin, MD    713-500-5800    Ashley.N.Morin@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Ashley N Morin, MD The University of Texas Health Science Center, Houston
More Information
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Responsible Party: Ashley N Morin, Fellow, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04531566    
Other Study ID Numbers: HSC-MS-20-0741
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ashley N Morin, The University of Texas Health Science Center, Houston:
Prematurity
Oral Skills
Nasal CPAP oral feeds
HFNC oral feeds
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications