The Effect of Oxygen Exposure During Newborn Resuscitation on Lung Injury
Oxygen Exposure During Newborn Resuscitation and Pulmonary Oxidative Stress
Sponsor: Equipment loan from Masimo Corp.
This NA trial investigates Oxidative Pulmonary Injury and Prematurity and is currently completed. Equipment loan from Masimo Corp. leads this study, which shows 5 recorded versions since 2005 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)Immediately prior to birth, preterm infants (\<= 32 weeks gestation) will be randomized to one of three groups: 1. Low Oxygen Burden (LOB) - initiation of resuscitation with 21% 02, II. Moderate Oxygen Burden (MOB) - initiation of resuscitation with 100% 02 and III. High Oxygen Burden (HOB) - 100% 02 used for the entire resuscitation. A pulse oximetry monitor will be connected to a probe on the infant's hand to measure the transcutaneous hemoglobin saturation with oxygen (Sp02). Adjustments to the inspired oxygen concentration will be made every 15 seconds for infants in the LOB and MOB groups to achieve a target Sp02 range of 85-92%. Resuscitation will otherwise proceed as per standard of care. The intervention will end upon arrival in the neonatal intensive care unit.
Immediately prior to birth, preterm infants (\<= 32 weeks gestation) will be randomized to one of three groups: 1. Low Oxygen Burden (LOB) - initiation of resuscitation with 21% 02, II. Moderate Oxygen Burden (MOB) - initiation of resuscitation with 100% 02 and III. High Oxygen Burden (HOB) - 100% 02 used for the entire resuscitation. A pulse oximetry monitor will be connected to a probe on the infant's hand to measure the transcutaneous hemoglobin saturation with oxygen (Sp02). Adjustments to the inspired oxygen concentration will be made every 15 seconds for infants in the LOB and MOB groups to achieve a target Sp02 range of 85-92%. Resuscitation will otherwise proceed as per standard of care. The intervention will end upon arrival in the neonatal intensive care unit.
Status Flow
Change History
5 versions recorded-
Sep 2024 — Present [monthly]
Completed NA
-
Jul 2024 — Sep 2024 [monthly]
Completed NA
-
Jan 2021 — Jul 2024 [monthly]
Completed NA
-
Jun 2018 — Jan 2021 [monthly]
Completed NA
-
Jan 2017 — Jun 2018 [monthly]
Completed NA
First recorded
Jul 2005
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Equipment loan from Masimo Corp.
- University of Calgary
For direct contact, visit the study record on ClinicalTrials.gov .