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

Oxidative Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697904
• Other study ID #: STU 052011-044
• Status: Completed
• Phase: N/A
• First received: September 25, 2012
• Last updated: October 1, 2012
• Start date: August 2010
• Est. completion date: January 2011

Study information

• Verified date: September 2012
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Oxidative Stress
• Premature Birth
• Prematurity

Intervention

Procedure:
• Titration of oxygen during newborn resuscitation in delivery room

Locations

Country	Name	City	State
United States	Parkland Memorial Hospital	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Total oxygen load used during active resuscitation		First 10 minutes of life	No
Secondary	Saturations achieved during first 10 minutes of life		First 10 minutes of life	No
Secondary	Significant bradycardia ( HR<60 beats per minute) after 90 seconds in either group during active resuscitation		First 10 minutes of life	No
Secondary	Time spent with saturation above 94% during active resuscitation		First 10 minutes of life	No
Secondary	Need for respiratory support in the delivery room		First 10 minutes of life	No
Secondary	Bronchopulmonary dysplasia		36 weeks postconceptional age	No
Secondary	Length of hospitalization		From date of randomization to date of discharge, expected average of 8 weeks	No
Secondary	Retinopathy of Prematurity		40 weeks postconceptional age	No
Secondary	Neonatal mortality		28 days of life	No
Secondary	Death before discharge		From date of randomization to date of discharge, expected average of 8 weeks	No