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Feeding Premature Infants During Non-invasive Respiratory Support

Primary Purpose

Premature Infant, Non-invasive Respiratory Support

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Length of feeding
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premature Infant

Eligibility Criteria

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

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).

Sites / Locations

  • Rambam Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Bolus gavage feeds

Continuous feeds

Arm Description

Bolus gavage feeds over 15-30 minutes

Continuous feeds over 2.0 hrs

Outcomes

Primary Outcome Measures

Oxygenation instability as documented by oxygen saturation histograms
Time to full feeds (TFF) defined as full enteral gavage feeding of 150 cc/Kg/day

Secondary Outcome Measures

Respiratory-length of respiratory support
Incidence of Necrotising enterocolitis (NEC) as defined by the medical team

Full Information

First Posted
February 20, 2019
Last Updated
February 21, 2019
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT03852641
Brief Title
Feeding Premature Infants During Non-invasive Respiratory Support
Official Title
Feeding Very-low-birth-weight (VLBW) Premature Infants (<1500g) During Non-invasive Respiratory Support- Continuous Drip Vs. Bolus Gavage Feeding
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A randomized control trial comparing bolus gavage feeds to continuous feed among premature infants supported by non-invasive respiratory support

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Infant, Non-invasive Respiratory Support

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bolus gavage feeds
Arm Type
Experimental
Arm Description
Bolus gavage feeds over 15-30 minutes
Arm Title
Continuous feeds
Arm Type
Experimental
Arm Description
Continuous feeds over 2.0 hrs
Intervention Type
Other
Intervention Name(s)
Length of feeding
Intervention Description
Feeds will be given via nasogastric tube over 15-30 min versus 2 hr
Primary Outcome Measure Information:
Title
Oxygenation instability as documented by oxygen saturation histograms
Time Frame
before dischatge home at an average of 40 weeks gestation
Title
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
Secondary Outcome Measure Information:
Title
Respiratory-length of respiratory support
Time Frame
before dischatge home at an average of 40 weeks gestation
Title
Incidence of Necrotising enterocolitis (NEC) as defined by the medical team
Time Frame
before dischatge home at an average of 40 weeks gestation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liron Borenstein-Levin, MD
Phone
04-7774125
Email
liron.boren@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liron Borenstein-Levin, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liron Borenstein-Levin, MD
Phone
972542243556
Email
L_BORENSTEIN@rambam.health.gov.il

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Feeding Premature Infants During Non-invasive Respiratory Support

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