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Delayed Cord Clamping with Oxygen for Premature Birth (DOXIE Trial)

N/A
Recruiting
Led By Anup Katheria, MD
Research Sponsored by Sharp HealthCare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Up to 28+6 weeks gestational age
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 22-26 months corrected age
Awards & highlights

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.

Who is the study for?
This trial is for preterm infants born up to 28+6 weeks gestational age, from any type of delivery and pregnancy. It's not for those with early membrane rupture before 20 weeks, congenital anomalies, fetal/maternal compromise, or if parents decline consent or resuscitation.Check my eligibility
What is being tested?
The study compares two groups of extremely premature babies during delayed cord clamping: one receives high oxygen concentration (100%) and the other low oxygen concentration (30%), to see which helps achieve better oxygen levels by 5 minutes after birth.See study design
What are the potential side effects?
Potential side effects may include risks associated with varying oxygen levels such as respiratory issues or imbalances in blood gases that could affect the infant's overall condition.

DOXIE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am currently 28 weeks and 6 days pregnant or less.

DOXIE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~22-26 months corrected age
This trial's timeline: 3 weeks for screening, Varies for treatment, and 22-26 months corrected age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of administration of oxygen during delayed cord clamping and it's impact on the incidence of preterm infants (up to 28 +6 weeks) who achieve a peripheral oxygen saturation of 80 percent by 5 minutes of life
Secondary outcome measures
All Grade IVH
Changes in heart rate (BPM) in the first 10 minutes of life
Frequency of Grade III and IV intraventricular hemorrhage
+1 more
Other outcome measures
Average Heart rate in the first 5 minutes after birth
Average oxygen saturation in the first 5 minutes after birth
Blood pressures in the first 24 hours of life
+38 more

DOXIE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DCC and High Oxygen ConcentrationExperimental Treatment1 Intervention
During 90 seconds of delayed cord clamping, the infant will receive gentle stimulation and start CPAP by 30 seconds of life at an FiO2 1.0, with CPAP of 5 cmH20. If the infant is apneic or there is no Pedicap color change the team will begin positive pressure ventilation (starting PIP of 20 cmH20) by 60 seconds of life. The infant will remain on this support up until the umbilical cord is clamped at 90 seconds or greater. Once the cord is clamped the infant resuscitation will continue according to unit protocol.
Group II: DCC and Low Oxygen ConcentrationActive Control1 Intervention
During 90 seconds of delayed cord clamping, the infant will receive gentle stimulation and start CPAP by 30 seconds of life at an FiO2 .30, with CPAP of 5 cmH20. If the infant is apneic or there is no Pedicap color change the team will begin positive pressure ventilation (starting PIP of 20 cmH20) by 60 seconds of life. The infant will remain on this support up until the umbilical cord is clamped at 90 seconds or greater. Once the cord is clamped the infant resuscitation will continue according to unit protocol.

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,672,419 Total Patients Enrolled
Sharp Mary Birch Hospital for Women & NewbornsOTHER
12 Previous Clinical Trials
6,402 Total Patients Enrolled
Sharp HealthCareLead Sponsor
40 Previous Clinical Trials
17,004 Total Patients Enrolled

Media Library

Delayed Cord Clamping with High Oxygen concentration (NA) Clinical Trial Eligibility Overview. Trial Name: NCT04413097 — N/A
Neonatal Hypoxia Research Study Groups: DCC and High Oxygen Concentration, DCC and Low Oxygen Concentration
Neonatal Hypoxia Clinical Trial 2023: Delayed Cord Clamping with High Oxygen concentration Highlights & Side Effects. Trial Name: NCT04413097 — N/A
Delayed Cord Clamping with High Oxygen concentration (NA) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04413097 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
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~30 spots leftby Dec 2024