Comparison of Different Oxygen Delivery Strategies During Resuscitation of Babies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00356902
Recruitment Status : Completed
First Posted : July 27, 2006
Last Update Posted : September 18, 2007
Alberta Children's Hospital
Masimo Corp - Equipment loan
Datex Ohmeda - Equipment loan
Information provided by:
University of Calgary

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Prematurity Oxidative Injury Respiratory Distress Procedure: titration of oxygen during resuscitation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effect of Titrating Oxygen Concentration During Resuscitation of the Newborn on Achieving Normoxemia
Study Start Date : July 2005
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Primary Outcome Measures :
  1. Proportion of time spent in normoxemia (85-92%)during resuscitation

Information from the National Library of Medicine

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Ages Eligible for Study:   23 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00356902

Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
University of Calgary
Alberta Children's Hospital
Masimo Corp - Equipment loan
Datex Ohmeda - Equipment loan
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 Identifier: NCT00356902     History of Changes
Other Study ID Numbers: RT732656
First Posted: July 27, 2006    Key Record Dates
Last Update Posted: September 18, 2007
Last Verified: September 2007