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

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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

Tracking Information
First Submitted Date  ICMJE April 14, 2016
First Posted Date  ICMJE April 19, 2016
Last Update Posted Date October 27, 2020
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2020)
Intraventricular Hemorrhage on Head Ultrasound [ Time Frame: 7-10 days after birth ]
presence of any grade IVH on HUS
Original Primary Outcome Measures  ICMJE
 (submitted: April 18, 2016)
Intraventricular Hemorrhage on Head Ultrasound [ Time Frame: 7-10 days after birth ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2020)
  • Adverse Events in the Delivery Room [ Time Frame: First one hour after birth ]
    number of adverse events in the delivery room
  • Adverse Hematologic and Cardiovascular Events [ Time Frame: First 24 hours after birth ]
    number of adverse hematologic/cardiac events
  • Adverse Hematologic and Respiratory Events [ Time Frame: First 10 days after birth ]
    number of adverse hematologic/respiratory events
  • 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
  • Adverse Findings on Late Head Ultrasound [ Time Frame: Birth through 36 weeks Post-Menstrual Age ]
    number of adverse findings on the late head ultrasound
Original Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2016)
  • Adverse Events in the Delivery Room [ Time Frame: First one hour after birth ]
  • Adverse Hematologic and Cardiovascular Events [ Time Frame: First 24 hours after birth ]
  • Adverse Hematologic and Respiratory Events [ Time Frame: First 10 days after birth ]
  • Adverse Prematurity-Related Events through 36 Weeks Post-Menstrual Age [ Time Frame: Birth through 36 Weeks Post-Menstrual Age ]
  • Adverse Findings on Late Head Ultrasound [ Time Frame: Birth through 36 weeks Post-Menstrual Age ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VentFirst: A Multicenter RCT of Assisted Ventilation During Delayed Cord Clamping for Extremely Preterm Infants
Official Title  ICMJE VentFirst: A Multicenter RCT of Assisted Ventilation During Delayed Cord Clamping for Extremely Preterm Infants
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Intraventricular Hemorrhage
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Standard 30-60 Seconds 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.
    Intervention: Procedure: VentFirst 120 Seconds Cord Clamping
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 18, 2016)
940
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Gina Snow (434) 924-9553 GMS4X@virginia.edu
Contact: April Muniz (434) 243-5350 am4pf@hscmail.mcc.virginia.edu
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02742454
Other Study ID Numbers  ICMJE 18783
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Karen Fairchild, MD, University of Virginia
Study Sponsor  ICMJE University of Virginia
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Karen Fairchild, MD University of Virginia
PRS Account University of Virginia
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP