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Completed

NCT Number: NCT01697904

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Parkland Memorial Hospital

Dallas, Texas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Titration of oxygen during newborn resuscitation in delivery room

Procedure

Primary outcomes

  1. Reduction in mean oxidative balance ratio at 1 hour of life

    Time frame: 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 outcomes

  1. Total oxygen load used during active resuscitation

    Time frame: First 10 minutes of life

  2. Saturations achieved during first 10 minutes of life

    Time frame: First 10 minutes of life

  3. Significant bradycardia ( HR<60 beats per minute) after 90 seconds in either group during active resuscitation

    Time frame: First 10 minutes of life

  4. Time spent with saturation above 94% during active resuscitation

    Time frame: First 10 minutes of life

  5. Need for respiratory support in the delivery room

    Time frame: First 10 minutes of life

  6. Bronchopulmonary dysplasia

    Time frame: 36 weeks postconceptional age

  7. Length of hospitalization

    Time frame: From date of randomization to date of discharge, expected average of 8 weeks

  8. Retinopathy of Prematurity

    Time frame: 40 weeks postconceptional age

  9. Neonatal mortality

    Time frame: 28 days of life

  10. Death before discharge

    Time frame: From date of randomization to date of discharge, expected average of 8 weeks

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 2, 2012
Registry last updated
Oct 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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