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

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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

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.
    



Study Type

Interventional


Primary Outcome

Oxygenation instability


Condition

Premature Infant

Intervention

Position change

Study Arms / Comparison Groups

 Supine
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

23

Start Date

January 1, 2018

Completion Date

March 30, 2020

Primary Completion Date

December 31, 2019

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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT03546543

Organization ID

0167-17-RMB


Responsible Party

Principal Investigator

Study Sponsor

Rambam Health Care Campus


Study Sponsor

, , 


Verification Date

March 2020