Back to resultsThe Effect of Feeding Length on the Oxygenation Instability Among Premature Infants
Primary Purpose
Premature Infant, Respiratory Disease
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Continuous gavage feeding
Bolus feeding
Sponsored by
About this trial
This is an interventional supportive care trial for Premature Infant
Eligibility Criteria
Inclusion Criteria:
Premature Infants (GA<37weeks) on non-invasive respiratory support (CPAP, NIPPV, HFNC) Feeding>100 ml/kg/day
Exclusion Criteria:
Congenital anomalies e.g. gastroschesis, congenital diaphragmatic hernia, cyanotic heart disease.
Instability because of:
Acute lung pathology for example x-ray confirmed pneumonia, air leak Active culture proven sepsis Need for inotropic support for low blood pressure
Sites / Locations
- Rambam Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Bolus feeding
continuous gavage feeding
Arm Description
Outcomes
Primary Outcome Measures
Oxygenation instability
SPO2 histogram documents the oxygenation stability. we will record the histogram at the end of each period of time and compare it
Secondary Outcome Measures
Full Information
NCT ID
NCT03748472
First Posted
November 19, 2018
Last Updated
April 27, 2022
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT03748472
Brief Title
The Effect of Feeding Length on the Oxygenation Instability Among Premature Infants
Official Title
The Effects of Bolus Feeding as Compared to Continuous Gavage Feeding on the Oxygenation Instability During Feeds Among Premature Infants
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 29, 2019 (Actual)
Primary Completion Date
December 13, 2020 (Actual)
Study Completion Date
March 1, 2022 (Actual)
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
SpO2 instability is in the nature of premature infants. Hypoxic episodes occur spontaneously in many of these infants, especially after the first week of life. Different interventions have been shown to influence the incidence of hypoxemic episodes in premature infants. Premature infants are fed via an NG/OG tube. Feeding length might influence the oxygenation instability among premature infants therefore the aim of this study is to evaluate the changes in oxygenation among preterm infants receiving respiratory support when are fed over 30 min vs over 2 hours, as documented by SpO2 histograms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Infant, Respiratory Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bolus feeding
Arm Type
Experimental
Arm Title
continuous gavage feeding
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Continuous gavage feeding
Intervention Description
Each subject will serve as his or her own control. In this arm infants will receive their feed over 2 hours and the next feed will be given over 30 min and then over 2 hours again.
Intervention Type
Procedure
Intervention Name(s)
Bolus feeding
Intervention Description
Each subject will serve as his or her own control. In this arm infants will receive their feed over 30 min and the next feed will be given over 2 hours and then over 30 minutes again.
Primary Outcome Measure Information:
Title
Oxygenation instability
Description
SPO2 histogram documents the oxygenation stability. we will record the histogram at the end of each period of time and compare it
Time Frame
9 hours (3 feeds)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Premature Infants (GA<37weeks) on non-invasive respiratory support (CPAP, NIPPV, HFNC) Feeding>100 ml/kg/day
Exclusion Criteria:
Congenital anomalies e.g. gastroschesis, congenital diaphragmatic hernia, cyanotic heart disease.
Instability because of:
Acute lung pathology for example x-ray confirmed pneumonia, air leak Active culture proven sepsis Need for inotropic support for low blood pressure
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effect of Feeding Length on the Oxygenation Instability Among Premature Infants
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