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Assisted Ventilation
VentFirst for Extremely Preterm Infants
N/A
Waitlist Available
Led By Karen Fairchild, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at admission to the neonatal intensive care unit
Awards & highlights
Study Summary
This trial will compare the effects of two different methods of providing ventilatory assistance to preterm infants.
Eligible Conditions
- Intraventricular Hemorrhage
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 minute, 5 minutes, and 10 minutes after delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 minute, 5 minutes, and 10 minutes after delivery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Intraventricular Hemorrhage on Head Ultrasound or death before 7 days of age
Secondary outcome measures
5 minute Apgar Score <5
Death
Lowest hematocrit in first 24 hours
+3 moreOther outcome measures
Admission hypothermia <36.5°C
Apgar scores
Bronchopulmonary Dysplasia (BPD)
+27 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: VentFirst 120 Seconds Cord ClampingExperimental Treatment1 Intervention
Assisted ventilation (face mask continuous positive airway pressure, CPAP, or positive pressure ventilation, PPV) is provided prior to cord clamping at 120 seconds.
Group II: Standard 30-60 Seconds Cord ClampingActive Control1 Intervention
Standard treatment for extremely preterm infants which is delayed cord clamping 30-60 seconds after birth, and assisted ventilation after cord clamping.
Find a Location
Who is running the clinical trial?
Indiana UniversityOTHER
980 Previous Clinical Trials
982,591 Total Patients Enrolled
Brigham and Women's HospitalOTHER
1,608 Previous Clinical Trials
11,469,307 Total Patients Enrolled
Mayo ClinicOTHER
3,205 Previous Clinical Trials
3,766,214 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are carrying more than two fetuses (babies) at once.The baby growing inside you has a very serious health problem that could be life-threatening.You are expecting identical twins who share the same placenta or amniotic sac.You are experiencing a serious medical emergency that requires immediate delivery, such as a placental abruption.The doctor or baby specialist thinks that the study treatment might not be suitable for you or your baby based on your health condition.You have chosen to receive only comfort care instead of treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Standard 30-60 Seconds Cord Clamping
- Group 2: VentFirst 120 Seconds Cord Clamping
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what geographic areas is this clinical trial being conducted?
"The trial is actively recruiting both in Charlottesville, Portland and Calgary as well as 11 other sites. The University of Virginia, Oregon Health & Science University and the University of Calgary are all officially registered locations for this medical experiment."
Answered by AI
Does this trial have an open enrollment period at present?
"The clinical trial, which was first announced in June of 2016 and recently updated on July 18th 2022, is still recruiting patients according to information available from clinicaltrials.gov."
Answered by AI
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