Comparison of Different Oxygen Delivery Strategies During Resuscitation of Babies

This study has been completed.
Sponsor:
Collaborators:
Alberta Children's Hospital
Masimo Corp - Equipment loan
Datex Ohmeda - Equipment loan
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00356902
First received: July 25, 2006
Last updated: September 14, 2007
Last verified: September 2007
  Purpose

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 Intervention
Prematurity
Oxidative Injury
Respiratory Distress
Procedure: titration of oxygen during resuscitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of Titrating Oxygen Concentration During Resuscitation of the Newborn on Achieving Normoxemia

Resource links provided by NLM:


Further study details as provided by University of Calgary:

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

Estimated Enrollment: 215
Study Start Date: July 2005
Study Completion Date: September 2007
  Eligibility

Ages Eligible for Study:   23 Weeks to 32 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356902

Locations
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
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00356902     History of Changes
Other Study ID Numbers: RT732656
Study First Received: July 25, 2006
Last Updated: September 14, 2007
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on October 30, 2014