Comparison of Different Oxygen Delivery Strategies During Resuscitation of Babies

September 14, 2007 updated by: University of Calgary

Effect of Titrating Oxygen Concentration During Resuscitation of the Newborn on Achieving Normoxemia

Preterm infants are born with immature lungs and often require help with breathing shortly after birth. This currently involves administering 100% oxygen. Unfortunately, delivery of high oxygen concentrations leads to the production of free radicals that can injure many organ systems. Term and near-term newborns deprived of oxygen during or prior to birth respond as well or better to resuscitation with room air (21% oxygen) compared to 100% oxygen. However, a static concentration of 21% oxygen may be inappropriate for preterm infants with lung disease. Our study will investigate how adjusting the amount of oxygen given to sick preterm newborns will affect the ability to maintain a safe oxygen level in their blood. Each infant will be assigned to receive one of three treatments at birth. Resuscitation will either start with 21% oxygen and be increased if needed, 100% oxygen and be decreased if needed or 100% oxygen with no changes made (current standard of treatment). The first two groups will have adjustments in oxygen concentration as needed to reach a safe target range of blood oxygen saturation. We anticipate that preterm newborn infants resuscitated with higher oxygen concentrations will have higher than "normal" levels of oxygen in their blood while those resuscitated initially with lower concentrations of oxygen will be more likely to have "normal" oxygen levels in their blood. All premature infants will have a surface probe placed on the right hand to measure the saturation of blood with oxygen. Following the resuscitation, treatment will proceed as per standard of care until hospital discharge. All infants will be admitted to the neonatal intensive care unit given their prematurity. The purpose of this study is to investigate how safely restricting the amount of oxygen delivered to newborns during resuscitation will affect the amount of oxygen in their blood.

Hypothesis: In this randomized control trial, infants resuscitated with a "low oxygen delivery (LOD)" strategy (initiation of resuscitation with 21% O2) will remain normoxemic for the greatest proportion of time during resuscitation and infants resuscitated with a "high oxygen delivery (HOD)" strategy (100% O2 used for the entire resuscitation) will be normoxemic for the smallest proportion of time during resuscitation.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

215

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • inborn
  • <= 32 weeks gestation
  • respiratory support needed during resuscitation. Respiratory support is defined as provision of continuous positive airway pressure or positive pressure ventilation delivered via either a face mask or an endotracheal tube.

Exclusion Criteria:

  • lethal anomalies
  • cyanotic congenital heart disease
  • known hemoglobinopathy
  • risk of persistent pulmonary hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Proportion of time spent in normoxemia (85-92%)during resuscitation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yacov Rabi, MD, FRCPC, University of Calgary
  • Principal Investigator: Wendy H Yee, MD, FRCPC, University of Calgary
  • Principal Investigator: Sophie Y Chen, MD, MSc, University of Calgary
  • Principal Investigator: Nalini Singhal, MD, FRCPC, University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

July 25, 2006

First Submitted That Met QC Criteria

July 26, 2006

First Posted (Estimate)

July 27, 2006

Study Record Updates

Last Update Posted (Estimate)

September 18, 2007

Last Update Submitted That Met QC Criteria

September 14, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Other Study ID Numbers

  • RT732656

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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