Oxidative Stress, Prematurity
Conditions
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.
Interventions
PROCEDURETitration of oxygen during newborn resuscitation in delivery room
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Inborn * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in mean oxidative balance ratio at 1 hour of life | 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
| Measure | Time frame |
|---|---|
| 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 |
| Total oxygen load used during active resuscitation | First 10 minutes of life |
| 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 |
| Bronchopulmonary dysplasia | 36 weeks postconceptional age |
Countries
United States
Outcome results
None listed