Parkland Memorial Hospital
Dallas, Texas, United States
NCT Number: NCT01697904
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.
Looking for future studies?
Notify MeAll sexes
Interventional
Not applicable
Dallas, Texas, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: First 10 minutes of life
Time frame: First 10 minutes of life
Time frame: First 10 minutes of life
Time frame: First 10 minutes of life
Time frame: First 10 minutes of life
Time frame: 36 weeks postconceptional age
Time frame: From date of randomization to date of discharge, expected average of 8 weeks
Time frame: 40 weeks postconceptional age
Time frame: 28 days of life
Time frame: From date of randomization to date of discharge, expected average of 8 weeks
University of Texas Southwestern Medical Center
Other
Randomized Trial of a Limited Versus Traditional Oxygen Strategy During Resuscitation in Premature Newborns
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.
Published trials that share one or more normalized conditions with this study.
NCT07689669
Apnea, Apnea of Prematurity
Konya, Turkey (Türkiye)
View Trial DetailsNCT07622459
Female Urogenital Diseases and Pregnancy Complications, Mechanical Ventilation
Sanliurfa, Turkey (Türkiye)
View Trial DetailsNCT07577180
Bronchopulmonary Dysplasia, Bronchopulmonary Dysplasia (BPD)
Köseköy, Kocaeli, Turkey (Türkiye)
View Trial DetailsNCT07494123
Carbohydrate Metabolism, Inborn Errors, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Cairo, Cairo Governorate, Egypt
View Trial Details