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

NCT03546543 | Completed

• 1 other identifier: 0167-17-RMB
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Infant; Bronchopulmonary Dysplasia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Supine

EXPERIMENTAL

Procedure: Position change

Prone

EXPERIMENTAL

Procedure: Position change

Interventions

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

Prone; Supine

Eligibility Criteria

• Age: 14 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Premature infants with a weight \< 1500 g who are receiving respiratory support

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Premature Birth; Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 6, 2018
• Study Start: January 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: March 30, 2020
• Last Updated: April 2, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)