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NCT01697904 · ClinicalTrials.gov registry record · NA
Trial of a Limited Versus Traditional Oxygen Strategy During Resuscitation in Premature Newborns
A NA study of Oxidative Stress and Prematurity, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 88
- Enrollment target
- 1
- Study location
NCT01697904: Completed NA study of Oxidative Stress and Prematurity, sponsored by University of Texas Southwestern Medical Center.
NCT01697904 is a NA study of Oxidative Stress and Prematurity that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 88 participants, roughly in line with the 84-participant average among 36 other Oxidative Stress trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01697904, a NA study of Oxidative Stress and Prematurity, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 88 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- PROCEDURE Titration of oxygen during newborn resuscitation in delivery room
Study Locations (1)
Texas
- Parkland Memorial Hospital - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2010-08 |
| Est. Completion | 2011-01 |
| Phase | NA |
What the finished NCT01697904 record still lists
NCT01697904 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, roughly in line with the 84-participant average among 36 other Oxidative Stress trials with a reported enrollment target.
The record links to 2 conditions, with Oxidative Stress appearing as the primary indexed condition, and to 1 intervention - of which Titration of oxygen during newborn resuscitation in delivery room is the first listed.
NCT01697904 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01697904 about?
NCT01697904 is a clinical study titled "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 n...
What is the current status of trial NCT01697904?
This trial is currently completed. It is a NA study. The enrollment target is 88 participants. The study started on 2010-08. Estimated completion is 2011-01.
What conditions does trial NCT01697904 study?
This clinical trial studies the following conditions: Oxidative Stress, Prematurity.
What interventions are being tested in trial NCT01697904?
The interventions under investigation include: Titration of oxygen during newborn resuscitation in delivery room (PROCEDURE).
Who is sponsoring clinical trial NCT01697904?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01697904 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01697904's enrollment target sits among peer trials
88 7th of 36 higher than 30 of 36 other Oxidative Stress trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Oxidative Stress trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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