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

Primary Purpose

Prematurity, Oxidative Stress

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Titration of oxygen during newborn resuscitation in delivery room
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prematurity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Parkland Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low Oxygen Strategy

Traditional Oxygen strategy ( TOX)

Arm Description

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%

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%

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Total oxygen load used during active resuscitation
Saturations achieved during first 10 minutes of life
Significant bradycardia ( HR<60 beats per minute) after 90 seconds in either group during active resuscitation
Time spent with saturation above 94% during active resuscitation
Need for respiratory support in the delivery room
Bronchopulmonary dysplasia
Length of hospitalization
Retinopathy of Prematurity
Neonatal mortality
Death before discharge

Full Information

First Posted
September 25, 2012
Last Updated
October 1, 2012
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01697904
Brief Title
Trial of a Limited Versus Traditional Oxygen Strategy During Resuscitation in Premature Newborns
Official Title
Randomized Trial of a Limited Versus Traditional Oxygen Strategy During Resuscitation in Premature Newborns
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity, Oxidative Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Oxygen Strategy
Arm Type
Experimental
Arm Description
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%
Arm Title
Traditional Oxygen strategy ( TOX)
Arm Type
Active Comparator
Arm Description
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%
Intervention Type
Procedure
Intervention Name(s)
Titration of oxygen during newborn resuscitation in delivery room
Primary Outcome Measure Information:
Title
Reduction in mean oxidative balance ratio at 1 hour of life
Description
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.
Time Frame
Cord blood and at 1 hour of life
Secondary Outcome Measure Information:
Title
Total oxygen load used during active resuscitation
Time Frame
First 10 minutes of life
Title
Saturations achieved during first 10 minutes of life
Time Frame
First 10 minutes of life
Title
Significant bradycardia ( HR<60 beats per minute) after 90 seconds in either group during active resuscitation
Time Frame
First 10 minutes of life
Title
Time spent with saturation above 94% during active resuscitation
Time Frame
First 10 minutes of life
Title
Need for respiratory support in the delivery room
Time Frame
First 10 minutes of life
Title
Bronchopulmonary dysplasia
Time Frame
36 weeks postconceptional age
Title
Length of hospitalization
Time Frame
From date of randomization to date of discharge, expected average of 8 weeks
Title
Retinopathy of Prematurity
Time Frame
40 weeks postconceptional age
Title
Neonatal mortality
Time Frame
28 days of life
Title
Death before discharge
Time Frame
From date of randomization to date of discharge, expected average of 8 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vishal S Kapadia, MD
Organizational Affiliation
UT Southwestern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Myra H Wyckoff, MD
Organizational Affiliation
UT Southwestern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkland Memorial Hospital
City
Dallas
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24218465
Citation
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.
Results Reference
derived

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

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