Back to resultsThe Effects of Position on the Oxygenation Instability of Premature Infants as Documented by SpO2 Histograms
Primary Purpose
Premature Infant, Bronchopulmonary Dysplasia
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Position change
Sponsored by
About this trial
This is an interventional supportive care trial for Premature Infant
Eligibility Criteria
Inclusion Criteria:
Premature infants with a weight < 1500 g who are receiving respiratory support
Exclusion Criteria:
Congenital anomalies, acute lung pathology for example x-ray confirmed pneumonia, air leak, active culture proven sepsis or on 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
Supine
Prone
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
1. Study Identification
Unique Protocol Identification Number
NCT03546543
Brief Title
The Effects of Position on the Oxygenation Instability of Premature Infants as Documented by SpO2 Histograms
Official Title
The Effects of Prone Versus Supine Position on the Oxygenation Instability of Premature Infants as Documented by SpO2 Histograms
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
March 30, 2020 (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. A few studies point towards potential clinical benefits of better oxygenation and less hypoxic events by positioning very low birth weight infants prone, though a recent meta-analysis didn't find a clear benefit of prone position.
The aim of this study is to evaluate the changes in oxygenation among preterm infants receiving respiratory support when positioned prone versus supine, 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, Bronchopulmonary Dysplasia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supine
Arm Type
Experimental
Arm Title
Prone
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Position change
Intervention Description
Each subject will serve as his or her own control. Half of the infants will be placed supine for 3 hours, followed by 3 hours of prone positioning and back to supine for 3 hours and the other half will be start in prone position with consecutive periods of supine and then prone
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
3 hours in each position
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Premature infants with a weight < 1500 g who are receiving respiratory support
Exclusion Criteria:
Congenital anomalies, acute lung pathology for example x-ray confirmed pneumonia, air leak, active culture proven sepsis or on 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
No
Learn more about this trial
The Effects of Position on the Oxygenation Instability of Premature Infants as Documented by SpO2 Histograms
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