Saturation Targets and Resuscitation in Preterm Trial

Completed · Not applicable

Conditions studied: Oxidative Stress

In brief

The purpose of this research project is to determine if use of optimized target oxygen strategy during delivery room resuscitation can reduce oxidative stress in premature newborns. Objective is to compare oxidative stress markers between preterm neonates resuscitated in the delivery room using three different target oxygen strategies. OX50 target oxygen strategy is currently in use and recommended by neonatal resuscitation program. In this strategy oxygen is adjusted to meet the goal transitional saturations which are approximated 50th centile saturations observed in healthy term newborns. In OX25 target oxygen strategy oxygen will be adjusted to meet the goal transitional saturations which are 25th percentile transitional saturations observed in healthy term newborns. In OX75 target oxygen strategy oxygen will be adjusted to meet the goal transitional saturations which are 75th percentile transitional saturations observed in healthy term newborns.

Key facts

Study ID

NCT03115463

Run by

University of Texas Southwestern Medical Center

People needed

75

Starts

2017-09-20

Expected to finish

2022-09-30

Last updated by the study team

2023-01-04

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Neonates of obstetric gestational age 23-30 weeks
• Inborn at Parkland Hospital, Dallas, Tx
• Resuscitation team present to initiate resuscitation

You may not qualify if…

• Prenatally diagnosed cyanotic congenital heart disease
• Prenatally diagnosed congenital diaphragmatic hernia
• Prenatally diagnosed significant airway anomaly
• Prenatally suspected hypoplasia of lungs
• Preductal saturation cannot be measured
• Non-viable newborns
• Prenatally diagnosed condition due to which decision is made to limit resuscitation in the delivery room by parents and neonatologist.

Where it is running

• Parkland Hospital — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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