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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vishal Kapadia, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01697904
First received: September 25, 2012
Last updated: October 1, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Prematurity
Oxidative Stress
Procedure: Titration of oxygen during newborn resuscitation in delivery room

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of a Limited Versus Traditional Oxygen Strategy During Resuscitation in Premature Newborns

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Reduction in mean oxidative balance ratio at 1 hour of life [ Time Frame: Cord blood and at 1 hour of life ] [ Designated as safety issue: No ]
    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 [ Time Frame: First 10 minutes of life ] [ Designated as safety issue: No ]
  • Saturations achieved during first 10 minutes of life [ Time Frame: First 10 minutes of life ] [ Designated as safety issue: No ]
  • Significant bradycardia ( HR<60 beats per minute) after 90 seconds in either group during active resuscitation [ Time Frame: First 10 minutes of life ] [ Designated as safety issue: No ]
  • Time spent with saturation above 94% during active resuscitation [ Time Frame: First 10 minutes of life ] [ Designated as safety issue: No ]
  • Need for respiratory support in the delivery room [ Time Frame: First 10 minutes of life ] [ Designated as safety issue: No ]
  • Bronchopulmonary dysplasia [ Time Frame: 36 weeks postconceptional age ] [ Designated as safety issue: No ]
  • Length of hospitalization [ Time Frame: From date of randomization to date of discharge, expected average of 8 weeks ] [ Designated as safety issue: No ]
  • Retinopathy of Prematurity [ Time Frame: 40 weeks postconceptional age ] [ Designated as safety issue: No ]
  • Neonatal mortality [ Time Frame: 28 days of life ] [ Designated as safety issue: No ]
  • Death before discharge [ Time Frame: From date of randomization to date of discharge, expected average of 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: August 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  1. min 60%-65%
  2. min 65%-70%
  3. min 70%-75%
  4. min 75%-80%
  5. 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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01697904

Locations
United States, Texas
Parkland Memorial Hospital
Dallas, Texas, United States
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Vishal S Kapadia, MD UT Southwestern
Principal Investigator: Myra H Wyckoff, MD UT Southwestern
  More Information

No publications provided by University of Texas Southwestern Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vishal Kapadia, Assistant Professor of Pediatrics, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01697904     History of Changes
Other Study ID Numbers: STU 052011-044
Study First Received: September 25, 2012
Last Updated: October 1, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications

ClinicalTrials.gov processed this record on October 23, 2014