What side effects are associated with this type of intervention?

Common treatments for neonatal hypoxia, such as supplemental oxygen, CPAP, and mechanical ventilation, can have several side effects. High oxygen concentration (FiO2 of 1.0) during delayed cord clamping (DCC) can lead to retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD), and oxidative stress. Lower oxygen concentration (FiO2 of 0.30) may reduce these risks but might not always provide sufficient oxygenation, potentially resulting in hypoxia-related complications.

What prior FDA approvals exist?

The FDA has approved various treatments for neonatal hypoxia, primarily focusing on oxygen therapy and respiratory support. Inhaled nitric oxide (iNO) is one such treatment, approved for term and near-term neonates with hypoxic respiratory failure. It acts as a selective pulmonary vasodilator, improving oxygenation. While the specific study on oxygen concentration during DCC compares high (FiO2 1.0) versus low (FiO2 0.30) oxygen levels, the broader context of FDA-approved treatments includes the use of controlled oxygen delivery and respiratory support systems to manage and prevent hypoxia in neonates.

What other types of research exist?

Promising novel alternatives to varying oxygen concentration during DCC for neonatal hypoxia include the use of advanced respiratory support techniques such as Continuous Positive Airway Pressure (CPAP) and Positive Pressure Ventilation (PPV) with precise oxygen titration. Additionally, the integration of real-time monitoring technologies to adjust oxygen delivery dynamically based on the infant's oxygen saturation levels could enhance outcomes. Research into the use of inhaled nitric oxide and other vasodilators during the immediate postnatal period may also offer new avenues for improving oxygenation in neonates with hypoxia.

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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

Must not have

Monochorionic multiples with evidence of TTTS

Bleeding accreta

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 22-26 months corrected age

Awards & highlights

No Placebo-Only Group

Summary

This trial tests whether giving preterm babies different oxygen levels while delaying umbilical cord clamping helps them breathe better. It focuses on very early preterm infants who often have trouble breathing. The goal is to see which method helps these babies get enough oxygen in their blood more quickly.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My twins share a placenta and have twin-to-twin transfusion syndrome.

Select...

I have been diagnosed with bleeding accreta.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 22-26 months corrected age

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Oxygen therapy is a primary treatment for neonatal hypoxia, aiming to increase the oxygen saturation in the blood of newborns. During delayed cord clamping (DCC), administering oxygen via mask CPAP/PPV with varying concentrations (FiO2) helps achieve optimal oxygen levels. High FiO2 (1.0) provides a greater immediate oxygen supply, potentially improving oxygenation more rapidly, while low FiO2 (0.30) aims to balance oxygenation with reduced risk of oxygen toxicity. This is crucial for neonatal hypoxia patients as appropriate oxygen levels are essential for preventing organ damage and supporting overall survival and development.

Nitric oxide for respiratory failure in infants born at or near term.Nitric oxide for respiratory failure in infants born at or near term.