- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03852641
Feeding Premature Infants During Non-invasive Respiratory Support
February 21, 2019 updated by: Liron Borenstein MD, Rambam Health Care Campus
Feeding Very-low-birth-weight (VLBW) Premature Infants (<1500g) During Non-invasive Respiratory Support- Continuous Drip Vs. Bolus Gavage Feeding
A randomized control trial comparing bolus gavage feeds to continuous feed among premature infants supported by non-invasive respiratory support
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Liron Borenstein-Levin, MD
- Phone Number: 04-7774125
- Email: liron.boren@gmail.com
Study Locations
-
-
-
Haifa, Israel
- Recruiting
- Rambam Medical Center
-
Contact:
- Liron Borenstein-Levin, MD
- Phone Number: 972542243556
- Email: L_BORENSTEIN@rambam.health.gov.il
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Infants <1500gr, on non-invasive respiratory support
- Feeding>20 ml/kg/day
Exclusion Criteria:
- Major congenital malformations
- Unstable infants because of sepsis, central nervous system, cardiac or other significant morbidities
- Gastrointestinal morbidity such as spontaneous intestinal perforation (SIP) and necrotising enterocolitis (NEC).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bolus gavage feeds
Bolus gavage feeds over 15-30 minutes
|
Feeds will be given via nasogastric tube over 15-30 min versus 2 hr
|
Experimental: Continuous feeds
Continuous feeds over 2.0 hrs
|
Feeds will be given via nasogastric tube over 15-30 min versus 2 hr
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Oxygenation instability as documented by oxygen saturation histograms
Time Frame: before dischatge home at an average of 40 weeks gestation
|
before dischatge home at an average of 40 weeks gestation
|
Time to full feeds (TFF) defined as full enteral gavage feeding of 150 cc/Kg/day
Time Frame: before dischatge home at an average of 40 weeks gestation
|
before dischatge home at an average of 40 weeks gestation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Respiratory-length of respiratory support
Time Frame: before dischatge home at an average of 40 weeks gestation
|
before dischatge home at an average of 40 weeks gestation
|
Incidence of Necrotising enterocolitis (NEC) as defined by the medical team
Time Frame: before dischatge home at an average of 40 weeks gestation
|
before dischatge home at an average of 40 weeks gestation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Liron Borenstein-Levin, MD, Rambam Health Care Campus
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2017
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
June 1, 2022
Study Registration Dates
First Submitted
February 20, 2019
First Submitted That Met QC Criteria
February 21, 2019
First Posted (Actual)
February 25, 2019
Study Record Updates
Last Update Posted (Actual)
February 25, 2019
Last Update Submitted That Met QC Criteria
February 21, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Feeding on NIPPV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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