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Sponsors and Collaborators: |
University of Calgary American Academy of Pediatrics |
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Information provided by: | University of Calgary |
ClinicalTrials.gov Identifier: | NCT00531102 |
Currently, newborns receive 100% supplemental oxygen by free flow when they remain cyanotic despite demonstrating regular respiratory effort. Resuscitating infants with continuous positive airway pressure (CPAP) in room air may improve oxygen saturations more quickly than providing FFO2 because of its ability to establish functional residual capacity in the lungs. Our primary hypothesis is that in this blinded, randomized control trial, more infants (≥35 weeks gestation) resuscitated with CPAP in room air will have an oxygen saturation ≥80% at five minutes of age compared to infants resuscitated with the 50% FFO2.
Condition | Intervention |
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Transition at Birth |
Other: continuous positive airway pressure Other: Free flow oxygen |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Effects of Oxygen and Functional Residual Capacity on the Oxygen Saturations of Infants ≥ 35 Weeks Gestation During Delivery Room Resuscitation. |
Estimated Enrollment: | 220 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Resuscitation will proceed as per standard of care and infants are only to receive respiratory support if they remain cyanotic despite 60 seconds of spontaneous regular respirations. All infants will have a pulse oximetry probe placed on the right hand (pre-ductal position) immediately after birth. Infants that meet the entry criteria will be randomized to resuscitation with one of two neonatal T-piece resuscitator circuits: GROUP 1 - infants will receive CPAP of 6 cm H2O with 21% oxygen continuously for at least 5 minutes. |
Other: continuous positive airway pressure
Infants will receive CPAP of 6 cm H2O with 21% oxygen continuously for at least 5 minutes
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2: Active Comparator
Resuscitation will proceed as per standard of care and infants are only to receive respiratory support if they remain cyanotic despite 60 seconds of spontaneous regular respirations. Infants that meet the entry criteria will be randomized to resuscitation with one of two neonatal T-piece resuscitator circuits: GROUP 2 - infants will receive 50% oxygen at a rate of 6 liters per minute continuously for at least 5 minutes using a modified neonatal T-piece resuscitator circuit that does not generate pressure. Fifty percent oxygen was chosen because it reflects the actual inspired oxygen concentration when 100% oxygen is blown towards the infant's face. |
Other: Free flow oxygen
Infants will receive 50% oxygen delivered by a modified neonatal T-piece resuscitator circuit that does not generate pressure for at least 5 minutes.
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Ages Eligible for Study: | up to 1 Minute |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Yacov Rabi, MD, FRCPC | 403-944-1615 | jack.rabi@calgaryhealthregion.ca |
Canada, Alberta | |
Foothills Hospital | Recruiting |
Calgary, Alberta, Canada, T2N 2T9 | |
Contact: Yacov Rabi, MD, FRCPC 403-944-1615 jack.rabi@calgaryhealthregion.ca | |
Sub-Investigator: Nalini Singhal, MD, FRCPC | |
Sub-Investigator: Amuchou Soraisham, MD, DM |
Principal Investigator: | Yacov Rabi, MD, FRCPC | University of Calgary |
Responsible Party: | University of Calgary ( Yacov Rabi MD ) |
Study ID Numbers: | RT733739 |
Study First Received: | September 17, 2007 |
Last Updated: | May 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00531102 |
Health Authority: | Canada: Health Canada |
oxygen continuous positive airway pressure infant, newborn resuscitation |