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VentFirst: A Multicenter RCT of Assisted Ventilation During Delayed Cord Clamping for Extremely Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02742454
Recruitment Status : Recruiting
First Posted : April 19, 2016
Last Update Posted : October 27, 2020
Sponsor:
Collaborators:
Brigham and Women's Hospital
Mayo Clinic
St. Louis University
University of Colorado, Denver
Oregon Health and Science University
University of Calgary
Columbia University
Indiana University
University of California, Davis
University of Alberta
Mount Sinai Hospital, Canada
University of Alabama at Birmingham
Information provided by (Responsible Party):
Karen Fairchild, MD, University of Virginia

Brief Summary:
The purpose of this study is to determine whether providing ventilatory assistance prior to umbilical cord clamping influences the occurrence of intraventricular hemorrhage (IVH) in extremely preterm (EPT) infants, compared to standard care of providing ventilatory assistance after cord clamping.

Condition or disease Intervention/treatment Phase
Intraventricular Hemorrhage Procedure: Standard 30-60 Seconds Cord Clamping Procedure: VentFirst 120 Seconds Cord Clamping Not Applicable

Detailed Description:

940 newborns with gestation 23 wks 0 days through 28 wks 6 days Randomized to Standard arm (delayed cord clamping for 30 seconds, or up to 60 seconds if breathing spontaneously) or VentFirst arm (receive CPAP or PPV from 30 sec to 120 sec).

Primary outcome is lack of IVH on 7-10 day head ultrasound.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 940 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: VentFirst: A Multicenter RCT of Assisted Ventilation During Delayed Cord Clamping for Extremely Preterm Infants
Study Start Date : June 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Active Comparator: Standard 30-60 Seconds Cord Clamping
Standard treatment for extremely preterm infants which is delayed cord clamping 30-60 seconds after birth, and assisted ventilation after cord clamping.
Procedure: Standard 30-60 Seconds Cord Clamping
The infant will be stimulated to breathe after birth. If the infant is not breathing well, the cord will be clamped at 30 seconds. If the baby is breathing well, the cord will be clamped at 60 seconds. Ventilatory assistance will be given after cord clamping.

Experimental: VentFirst 120 Seconds Cord Clamping
Assisted ventilation (face mask Continuous Positive Airway Pressure, CPAP, or Positive Pressure Ventilation, PPV) will be provided prior to cord clamping at 120 seconds.
Procedure: VentFirst 120 Seconds Cord Clamping
The infant will be stimulated to breathe after birth. If the infant is not breathing well, Positive Pressure Ventilation by face mask will be given starting at 30 seconds. If the baby is breathing well, Continuous Positive Airway Pressure (CPAP by face mask) will be given starting at 30 seconds. The cord will be clamped at 120 seconds.




Primary Outcome Measures :
  1. Intraventricular Hemorrhage on Head Ultrasound [ Time Frame: 7-10 days after birth ]
    presence of any grade IVH on HUS


Secondary Outcome Measures :
  1. Adverse Events in the Delivery Room [ Time Frame: First one hour after birth ]
    number of adverse events in the delivery room

  2. Adverse Hematologic and Cardiovascular Events [ Time Frame: First 24 hours after birth ]
    number of adverse hematologic/cardiac events

  3. Adverse Hematologic and Respiratory Events [ Time Frame: First 10 days after birth ]
    number of adverse hematologic/respiratory events

  4. Adverse Prematurity-Related Events through 36 Weeks Post-Menstrual Age [ Time Frame: Birth through 36 Weeks Post-Menstrual Age ]
    number of prematurity-related adverse events

  5. Adverse Findings on Late Head Ultrasound [ Time Frame: Birth through 36 weeks Post-Menstrual Age ]
    number of adverse findings on the late head ultrasound



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 23 0/7 - 28 6/7 weeks gestation at delivery.

Exclusion Criteria:

  • Life-threatening condition of fetus (e.g. severe hydrops, lethal chromosomal abnormality, severe congenital malformation)
  • Suspected severe fetal anemia
  • Monochorionic or monoamniotic twins
  • Multiple gestation greater than twins
  • Decision made for comfort care only
  • Medical emergency necessitating emergency delivery (e.g. complete placental abruption)
  • Obstetrician or Neonatology concern for inappropriateness of the study intervention based on maternal or fetal factors.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02742454


Contacts
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Contact: Gina Snow (434) 924-9553 GMS4X@virginia.edu
Contact: April Muniz (434) 243-5350 am4pf@hscmail.mcc.virginia.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35233
Contact: Cindie Buie, RN    205-934-6452    cbuie@peds.uab.edu   
Principal Investigator: Wally Carlo, MD         
Sub-Investigator: Colm Travers, MD         
United States, California
University of California, Davis Recruiting
Sacramento, California, United States, 95817
Contact: Rosa R Pesavento    916-734-8121    rpesavento@ucdavis.edu   
Principal Investigator: Mark Underwood, MD         
Principal Investigator: Francis Poulain, MD         
United States, Colorado
University of Colorado Recruiting
Denver, Colorado, United States, 80045-2571
Contact: Jessica Scott       Jessica.scott@childrenscolorado.org   
Principal Investigator: Susan Niermeyer, MD         
United States, Indiana
University of Indiana Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Dianne Herron    317-278-7285    dhwilson@iu.edu   
Principal Investigator: Bobbi J Byrne, MD         
United States, Massachusetts
Brigham & Women's Hospital Terminated
Boston, Massachusetts, United States, 02115-6110
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905-0001
Contact: Amy Amsbaugh    507-538-7538    amsbaugh.amy@mayo.edu   
Contact: Lavonne Liedl    507-255-1828    liedl.lavonne@mayo.edu   
United States, Missouri
St. Louis University Recruiting
Saint Louis, Missouri, United States, 63103-2006
Contact: Melissa Bowles-Hawkins    314-678-2192    mbowles2@slu.edu   
Principal Investigator: Marya Strand, MD         
United States, New York
Columbia University Medical Center Active, not recruiting
New York, New York, United States, 10032
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 37239-0000
Contact: Monica Rincon, MD       rincon@ohsu.edu   
Principal Investigator: Jamie Warren, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22904-4195
Contact: Monika Thielen, ART, BComm       MJT3C@hscmail.mcc.virginia.edu   
Canada, Alberta
University of Calgary Active, not recruiting
Calgary, Alberta, Canada, T2N 1N4
University of Alberta, Edmonton Recruiting
Edmonton, Alberta, Canada, T5H 3V9
Contact: Caroline Fray       caroline.fray@albertahealthservices.ca   
Principal Investigator: Georg Schmoelzer, MD         
Sub-Investigator: Brenda Law, MD         
Canada, Ontario
Mount Sinai Hospital, Toronto Not yet recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Emer Finan, MD    416-586-4800 ext 7346    Emer.Finan@sinaihealth.ca   
Principal Investigator: Emer Finan, MD         
Principal Investigator: Kin Fan Young Tai, MD         
Sponsors and Collaborators
University of Virginia
Brigham and Women's Hospital
Mayo Clinic
St. Louis University
University of Colorado, Denver
Oregon Health and Science University
University of Calgary
Columbia University
Indiana University
University of California, Davis
University of Alberta
Mount Sinai Hospital, Canada
University of Alabama at Birmingham
Investigators
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Principal Investigator: Karen Fairchild, MD University of Virginia
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Responsible Party: Karen Fairchild, MD, Professor of Pediatrics, University of Virginia
ClinicalTrials.gov Identifier: NCT02742454    
Other Study ID Numbers: 18783
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Karen Fairchild, MD, University of Virginia:
Umbilical Cord Clamping
Intraventricular Hemorrhage
Extremely Preterm Infants
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes