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

• ClinicalTrials.gov Identifier: NCT02742454
• Recruitment Status: Recruiting
• First Posted: April 19, 2016
• Last Update Posted: October 27, 2020
• Sponsor: University of Virginia
• 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: April 14, 2016
• First Posted Date: April 19, 2016
• Last Update Posted Date: October 27, 2020
• Study Start Date: June 2016
• Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: April 18, 2016): Intraventricular Hemorrhage on Head Ultrasound [ Time Frame: 7-10 days after birth ]

Current Secondary Outcome Measures (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 (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: VentFirst: A Multicenter RCT of Assisted Ventilation During Delayed Cord Clamping for Extremely Preterm Infants
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention
• Condition: Intraventricular Hemorrhage

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 18, 2016): 940
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2023
• Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Gina Snow; (434) 924-9553; GMS4X@virginia.edu

Contact: April Muniz; (434) 243-5350; am4pf@hscmail.mcc.virginia.edu

• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT02742454
• Other Study ID Numbers: 18783
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Karen Fairchild, MD, University of Virginia
• Study Sponsor: University of Virginia

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

Investigators

• Principal Investigator: Karen Fairchild, MD; University of Virginia

• PRS Account: University of Virginia
• Verification Date: October 2020