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NCT03546543 Clinical Trial

The Effects of Position on the Oxygenation Instability of Premature Infants as Documented by SpO2 Histograms

Bronchopulmonary Dysplasia Clinical Trial

Official title:
The Effects of Prone Versus Supine Position on the Oxygenation Instability of Premature Infants as Documented by SpO2 Histograms

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03546543
Other study ID # 0167-17-RMB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date March 30, 2020

Study information
Verified date March 2020
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 23
Est. completion date March 30, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Position change
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

Locations
Country Name City State
Israel Rambam Medical Center Haifa

Sponsors (1)
Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Oxygenation instability SPO2 histogram documents the oxygenation stability. we will record the histogram at the end of each period of time and compare it 3 hours in each position
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