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

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.

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Key information

Conditions

Premature Infant Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury

Age range

14 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rambam Medical Center

Haifa, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Position change

Procedure

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 outcomes

Oxygenation instability

Time frame: 3 hours in each position

SPO2 histogram documents the oxygenation stability. we will record the histogram at the end of each period of time and compare it

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2020
First posted: Jun 6, 2018
Registry last updated: Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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