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

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

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.

Study Overview

• Status: Completed
• Conditions: Oxidative Stress; Prematurity
• Intervention / Treatment: Procedure: Titration of oxygen during newborn resuscitation in delivery room

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States
      • Parkland Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Oxygen Strategy; Resuscitation was initiated with room air (21% O2) for LOX infants. Supplemental oxygen was given if 1) the heart rate (HR) was less than 100 bpm after 30 seconds of effective ventilation, 2) the lower limits of goal saturations were not met. Targeted goal Pre-ductal saturations after birth were derived by approximation of the interquartile values for healthy term infants as reported by Kamlin et al and Dawson et al.FiO2 was increased or decreased by 10% in 30 second intervals as needed. If HR < 60 bpm after 30 seconds of effective ventilation , FiO2 was increased to 100% until the heart rate was stabilized. Targeted Pre-ductal SpO2 After birth; min 60%-65%; min 65%-70%; min 70%-75%; min 75%-80%; min 80%-85% 10 min 85%-94%	Procedure: Titration of oxygen during newborn resuscitation in delivery room
Active Comparator: Traditional Oxygen strategy ( TOX); Resuscitation for TOX infants was started with 100% O2 and adjusted every 30 seconds by 10% to meet the target oxygen saturation range of 85-94%	Procedure: Titration of oxygen during newborn resuscitation in delivery room

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in mean oxidative balance ratio 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.	Cord blood and at 1 hour of life

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Vishal S Kapadia, MD, UT Southwestern; Principal Investigator: Myra H Wyckoff, MD, UT Southwestern

Publications and helpful links

General Publications

• Kapadia VS, Chalak LF, Sparks JE, Allen JR, Savani RC, Wyckoff MH. Resuscitation of preterm neonates with limited versus high oxygen strategy. Pediatrics. 2013 Dec;132(6):e1488-96. doi: 10.1542/peds.2013-0978. Epub 2013 Nov 11.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: September 25, 2012
• First Submitted That Met QC Criteria: October 1, 2012
• First Posted (Estimate): October 2, 2012

Study Record Updates

• Last Update Posted (Estimate): October 2, 2012
• Last Update Submitted That Met QC Criteria: October 1, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: STU 052011-044