Randomized Trial of a Limited Versus Traditional Oxygen Strategy During Resuscitation in Premature Newborns
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prematurity
- Sponsor
- University of Texas Southwestern Medical Center
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Reduction in mean oxidative balance ratio at 1 hour of life
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
Preterm infants are born with immature lungs and often require help with breathing shortly after birth. This traditionally 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.Purpose of the study is to investigate if preterm neonates where resuscitation is initiated with 21% fiO2 and adjusted to meet transitional goal saturations (Limited oxygen strategy or LOX) would have less oxidative stress as measured by the oxidative balance ratio of biological antioxidant potential/total hydroperoxide compared to infants where resuscitation is initiated with pure oxygen and titrated for targeted saturations of 85-94% (Traditional oxygen strategy or TOX). Secondary outcomes of interest included need for other delivery room resuscitation measures, respiratory support and ventilation/oxygenation status upon neonatal intensive care unit (NICU) admission, survival to hospital discharge, bronchopulmonary dysplasia and other short-term morbidities.
Investigators
Vishal Kapadia
Assistant Professor of Pediatrics
University of Texas Southwestern Medical Center
Eligibility Criteria
Inclusion Criteria
- •Gestation age 24 0/7 to 34 6/7
- •Need for active resuscitation
Exclusion Criteria
- •Prenatally diagnosed cyanotic congenital heart disease
- •Non-viable newborns
- •Precipitous delivery and resuscitation team not present in the delivery room to initiate resuscitation
Outcomes
Primary Outcomes
Reduction in mean oxidative balance ratio at 1 hour of life
Time Frame: Cord blood and at 1 hour of life
Total hydroperoxide(TH), Biological antioxidant potential (BAP)were measured at 1 hour of life in all preterm infants. Oxidative balance ratio was calculated from this formula. Oxidative balance ratio = BAP/TH.
Secondary Outcomes
- Total oxygen load used during active resuscitation(First 10 minutes of life)
- Saturations achieved during first 10 minutes of life(First 10 minutes of life)
- Significant bradycardia ( HR<60 beats per minute) after 90 seconds in either group during active resuscitation(First 10 minutes of life)
- Time spent with saturation above 94% during active resuscitation(First 10 minutes of life)
- Need for respiratory support in the delivery room(First 10 minutes of life)
- Bronchopulmonary dysplasia(36 weeks postconceptional age)
- Length of hospitalization(From date of randomization to date of discharge, expected average of 8 weeks)
- Retinopathy of Prematurity(40 weeks postconceptional age)
- Neonatal mortality(28 days of life)
- Death before discharge(From date of randomization to date of discharge, expected average of 8 weeks)