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VentFirst 120 Seconds Cord Clamping for Intraventricular Hemorrhage

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Intraventricular HemorrhageVentFirst 120 Seconds Cord Clamping - Procedure
Eligibility
Any Age
All Sexes
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Study Summary

This trial will compare the effects of two different methods of providing ventilatory assistance to preterm infants.

Eligible Conditions
  • Intraventricular Hemorrhage

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Standard of care
2
Risk Factor Management
1
ECT-001-CB (UM171-Expanded Cord Blood Transplant)

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: First 24 hours after birth

7-10 days after birth
Intraventricular Hemorrhage on Head Ultrasound
Week 36
Adverse Prematurity-Related Events through 36 Weeks Post-Menstrual Age
Week 36
Adverse Findings on Late Head Ultrasound
Day 10
Adverse Hematologic and Respiratory Events
Hour 24
Adverse Hematologic and Cardiovascular Events
First one hour after birth
Adverse Events in the Delivery Room

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Standard of care
3
Risk Factor Management
1
ECT-001-CB (UM171-Expanded Cord Blood Transplant)

Trial Design

2 Treatment Groups

Standard 30-60 Seconds Cord Clamping
1 of 2
VentFirst 120 Seconds Cord Clamping
1 of 2

Active Control

Experimental Treatment

940 Total Participants · 2 Treatment Groups

Primary Treatment: VentFirst 120 Seconds Cord Clamping · No Placebo Group · N/A

VentFirst 120 Seconds Cord Clamping
Procedure
Experimental Group · 1 Intervention: VentFirst 120 Seconds Cord Clamping · Intervention Types: Procedure
Standard 30-60 Seconds Cord Clamping
Procedure
ActiveComparator Group · 1 Intervention: Standard 30-60 Seconds Cord Clamping · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: first 24 hours after birth

Who is running the clinical trial?

University of VirginiaLead Sponsor
685 Previous Clinical Trials
1,426,108 Total Patients Enrolled
University of AlbertaOTHER
816 Previous Clinical Trials
375,884 Total Patients Enrolled
Mount Sinai Hospital, CanadaOTHER
183 Previous Clinical Trials
63,174 Total Patients Enrolled
University of Alabama at BirminghamOTHER
1,434 Previous Clinical Trials
2,228,282 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
893 Previous Clinical Trials
6,828,434 Total Patients Enrolled
St. Louis UniversityOTHER
186 Previous Clinical Trials
37,012 Total Patients Enrolled
Mayo ClinicOTHER
2,919 Previous Clinical Trials
3,516,040 Total Patients Enrolled
Indiana UniversityOTHER
876 Previous Clinical Trials
748,786 Total Patients Enrolled
University of CalgaryOTHER
705 Previous Clinical Trials
491,761 Total Patients Enrolled
University of Colorado, DenverOTHER
1,591 Previous Clinical Trials
1,926,323 Total Patients Enrolled
Brigham and Women's HospitalOTHER
1,480 Previous Clinical Trials
9,734,885 Total Patients Enrolled
University of California, DavisOTHER
843 Previous Clinical Trials
5,011,411 Total Patients Enrolled
Columbia UniversityOTHER
1,296 Previous Clinical Trials
1,612,519 Total Patients Enrolled
Karen Fairchild, MDPrincipal Investigator - University of Virginia
University of Virginia Medical Center
Duke University School Of Medicine (Medical School)
Children'S Hosp-Philadelphia (Residency)
1 Previous Clinical Trials
250 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 1 Total Inclusion Criteria

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References

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