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Trial of a Limited Versus Traditional Oxygen Strategy During Resuscitation in Premature Newborns

Not Applicable
Completed
Conditions
Prematurity
Oxidative Stress
Registration Number
NCT01697904
Lead Sponsor
University of Texas Southwestern Medical Center
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
88
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Reduction in mean oxidative balance ratio at 1 hour of lifeCord 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 Outcome Measures
NameTimeMethod
Total oxygen load used during active resuscitationFirst 10 minutes of life
Saturations achieved during first 10 minutes of lifeFirst 10 minutes of life
Significant bradycardia ( HR<60 beats per minute) after 90 seconds in either group during active resuscitationFirst 10 minutes of life
Time spent with saturation above 94% during active resuscitationFirst 10 minutes of life
Need for respiratory support in the delivery roomFirst 10 minutes of life
Bronchopulmonary dysplasia36 weeks postconceptional age
Length of hospitalizationFrom date of randomization to date of discharge, expected average of 8 weeks
Retinopathy of Prematurity40 weeks postconceptional age
Neonatal mortality28 days of life
Death before dischargeFrom date of randomization to date of discharge, expected average of 8 weeks

Trial Locations

Locations (1)

Parkland Memorial Hospital

🇺🇸

Dallas, Texas, United States

Parkland Memorial Hospital
🇺🇸Dallas, Texas, United States

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