Delayed Cord Clamping with High Oxygen concentration for Respiratory Failure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Respiratory Failure+7 More
Delayed Cord Clamping with High Oxygen concentration - Procedure
Eligibility
< 18
All Sexes
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Study 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.

Eligible Conditions
  • Respiratory Failure
  • Hypoxia
  • Premature Birth
  • Intraventricular Hemorrhage (IVH)
  • Hyperoxia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: 22-26 months corrected age

22-26 months corrected age
Neurodevelopmental Outcome at 2 Years of Age
24 months corrected age
Cerebral Palsy
Cognitive Composite Score
Language Composite Score
Motor Composite Score
6 hours of life
Left Ventricular Output
Pulsatility Index
RVO
Resistive Index
SVC Flow
Month 6
Severe ROP (stage 3 or treated with laser or bevacizumab)
Month 6
Duration of mechanical ventilation and/or CPAP
Intubation in the Delivery room or Neonatal Intensive Care Unit (NICU)
Day 10
Number of RBC Transfusions since birth
Hour 12
CRIB-II (Clinical Risk Index for Babies)
SNAPPE-II (Score for Neonatal Acute Physiology-Perinatal Extension)
Hour 24
Lowest and Highest Hemoglobin and/or Hematocrit
Systemic arterial pressure
Medication for Low Blood Pressure
Week 36
Bronchopulmonary Dysplasia (mode of respiratory support administered at 36 weeks postmenstrual age; as defined and categorized in; Jensen, Dysart, Gantz, et al: Defining Bronchopulmonary Dysplasia) http://www.ncbi.nlm.nih.gov/pmc/articles/pmc6775872/
Bronchopulmonary Dysplasia (receiving continuous supplemental oxygen at 36 weeks corrected gestational age
Laser Surgery
Month 6
Inhaled Nitric Oxide
Surfactant administration
In the first 10 minutes of life
Changes in Inspired fractional oxygen (FiO2)
Changes in Mean airway pressure, MAP (cm H20)
Changes in SpO2 (%) in the first 10 minutes of life
Changes in cerebral oxygen saturation, StO2 (%)
Changes in cerebral oxygenation saturation, StO2 (%)
Changes in heart rate (BPM) in the first 10 minutes of life
Resuscitation procedure
Hour 24
Blood pressures in the first 24 hours of life
Cerebral tissue oxygenation in the first 24 hours of life
The first 10 minutes of life in the delivery room
Hyperoxia
Hypoxia
Duration of Positive Pressure Ventilation
Month 6
Combined outcome of severe IVH and/or death
Death
Month 6
Necrotizing Enterocolitis
Patent Ductus Arteriosus requiring pharmacological or surgical treatment
Spontaneous Intestinal Perforation (SIP) requiring surgery or peritoneal drain
Month 6
All Grade IVH
Frequency of Grade III and IV intraventricular hemorrhage
by 5 minutes of life
Average Heart rate in the first 5 minutes after birth
Average oxygen saturation in the first 5 minutes after birth
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
Incidence of preterm infants (up to 28 +6 weeks) who achieve a peripheral oxygen saturation of 80 percent by 5 minutes of life
Hour 2
Glutathione (GSH/GSSG ratio)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

DCC and Low Oxygen Concentration
1 of 2
DCC and High Oxygen Concentration
1 of 2
Active Control
Experimental Treatment

140 Total Participants · 2 Treatment Groups

Primary Treatment: Delayed Cord Clamping with High Oxygen concentration · No Placebo Group · N/A

DCC and High Oxygen Concentration
Procedure
Experimental Group · 1 Intervention: Delayed Cord Clamping with High Oxygen concentration · Intervention Types: Procedure
DCC and Low Oxygen Concentration
Procedure
ActiveComparator Group · 1 Intervention: Delayed Cord Clamping with Low Oxygen concentration · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 22-26 months corrected age

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,805 Previous Clinical Trials
2,235,103 Total Patients Enrolled
2 Trials studying Respiratory Failure
395 Patients Enrolled for Respiratory Failure
Sharp Mary Birch Hospital for Women & NewbornsOTHER
10 Previous Clinical Trials
4,736 Total Patients Enrolled
Sharp HealthCareLead Sponsor
38 Previous Clinical Trials
16,438 Total Patients Enrolled
Anup Katheria, MDPrincipal InvestigatorSharp HealthCare
12 Previous Clinical Trials
10,037 Total Patients Enrolled

Eligibility Criteria

Age < 18 · All Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: October 20th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References