Clinical trial NCT01697904: 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
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity
Oxidative Stress
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2012-10-02
Enrollment: 88
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Reduction in mean oxidative balance ratio at 1 hour of life
timeFrame: Cord blood and at 1 hour of life
Secondary outcomes:
measure: Total oxygen load used during active resuscitation
timeFrame: First 10 minutes of life
measure: Saturations achieved during first 10 minutes of life
timeFrame: First 10 minutes of life
measure: Significant bradycardia ( HR<60 beats per minute) after 90 seconds in either group during active resuscitation
timeFrame: First 10 minutes of life
measure: Time spent with saturation above 94% during active resuscitation
timeFrame: First 10 minutes of life
measure: Need for respiratory support in the delivery room
timeFrame: First 10 minutes of life
measure: Bronchopulmonary dysplasia
timeFrame: 36 weeks postconceptional age
measure: Length of hospitalization
timeFrame: From date of randomization to date of discharge, expected average of 8 weeks
measure: Retinopathy of Prematurity
timeFrame: 40 weeks postconceptional age
measure: Neonatal mortality
timeFrame: 28 days of life
measure: Death before discharge
timeFrame: From date of randomization to date of discharge, expected average of 8 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Memorial Hospital
state: Texas
Study officials:
affiliation: UT Southwestern
name: Vishal S Kapadia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UT Southwestern
name: Myra H Wyckoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.