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

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2012-09
• Study First Submitted: 2012-09-25
• Study First Submitted QC: 2012-10-01
• Last Update Submitted: 2012-10-01
• Study First Posted: 2012-10-02
• Last Update Posted: 2012-10-02

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

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Parkland Memorial Hospital; 🇺🇸 Dallas, Texas, United States