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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 36 weeks' postmenstrual age
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if giving extremely preterm babies breathing support right after birth can reduce brain bleeding. The goal is to see if this early support helps stabilize their condition better than the usual method.
Eligible Conditions
- Intraventricular Hemorrhage
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at nicu admission
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at nicu admission
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Intraventricular Hemorrhage on Head Ultrasound or death before 7 days of age
Secondary study objectives
5 minute Apgar Score <5
Death
Lowest hematocrit in first 24 hours
+3 moreOther study objectives
Admission hypothermia <36.5°C
Apgar scores
Bronchopulmonary Dysplasia (BPD)
+27 moreAwards & 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: 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.
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Who is running the clinical trial?
Brigham and Women's HospitalOTHER
1,666 Previous Clinical Trials
11,839,665 Total Patients Enrolled
Indiana UniversityOTHER
1,039 Previous Clinical Trials
1,218,488 Total Patients Enrolled
University of California, DavisOTHER
943 Previous Clinical Trials
4,755,118 Total Patients Enrolled
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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.
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