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Delayed Cord Clamping with Oxygen for Premature Birth (DOXIE Trial)
DOXIE Trial Summary
This trial will compare the rate of preterm infants who achieve a peripheral oxygen saturation of 80 percent by 5 minutes of life given different levels of oxygen during DCC.
DOXIE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowDOXIE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.DOXIE Trial Design
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Who is running the clinical trial?
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- There is a risk to the mother or baby.My twins share a placenta and have twin-to-twin transfusion syndrome.I have been diagnosed with bleeding accreta.Your water broke too early, before 20 weeks of pregnancy.The baby is born with birth defects.I have given birth, regardless of the method.My parents have decided against resuscitation measures for me.You are pregnant with one baby or more than one baby.I am currently 28 weeks and 6 days pregnant or less.
- Group 1: DCC and High Oxygen Concentration
- Group 2: DCC and Low Oxygen Concentration
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many participants can partake in this research protocol?
"Affirmative. Clinicaltrials.gov records demonstrate that this medical experiment, which was initially made public on November 17th 2021, is currently seeking participants. Approximately 140 individuals need to be enrolled from 2 separate research centres."
Do I meet the prerequisites to join this investigation?
"This medical experiment is enlisting 140 individuals between 22 Weeks and 28 Weeks of age who are experiencing respiratory failure. Other criteria for inclusion include a maximum gestation period of 28+6 weeks, applicable to both single-fetus pregnancies as well as multiple births, with all modes delivery (vaginal or caesarean section) accepted."
Does this research encompass participants over eighty-five years old?
"Patients who wish to enter this clinical trial must be between 22 weeks and 28 weeks of age. For those under 18 years old, there are 136 medical trials available. Conversely, 548 studies cater specifically for older citizens over 65."
What outcome is this clinical investigation attempting to realize?
"This trial, which will be observed over five minutes of life, aims to detect the number of preterm infants (up to 28 weeks and 6 days) who reach an oxygen saturation rate at 80 percent. Secondary objectives encompass alterations in heart rates within 10 minutes post-birth, grade IV intraventricular hemorrhage frequency, and the incidence of grades III and IV parenchymal bleeding or ventricular dilation."
Are there still vacancies available for participants in this research project?
"Affirmative. The information posted on clinicaltrials.gov shows that this investigation, initially announced in November 2021, is actively recruiting participants and has already been updated at least once since then. In total, 140 patients are being sought from two different medical centres."
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