search
Back to results

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

Primary Purpose

Intraventricular Hemorrhage

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Standard 30-60 Seconds Cord Clamping
VentFirst 120 Seconds Cord Clamping
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intraventricular Hemorrhage focused on measuring Umbilical Cord Clamping, Intraventricular Hemorrhage, Extremely Preterm Infants

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • University of California, Davis
  • University of Colorado
  • University of Indiana
  • Brigham & Women's Hospital
  • Mayo Clinic
  • St. Louis University
  • Columbia University Medical Center
  • Oregon Health & Science University
  • University of Virginia
  • University of Calgary
  • University of Alberta, Edmonton

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard 30-60 Seconds Cord Clamping

VentFirst 120 Seconds Cord Clamping

Arm Description

Standard treatment for extremely preterm infants which is delayed cord clamping 30-60 seconds after birth, and assisted ventilation after 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.

Outcomes

Primary Outcome Measures

Intraventricular Hemorrhage on Head Ultrasound
presence of any grade IVH on HUS

Secondary Outcome Measures

Adverse Events in the Delivery Room
number of adverse events in the delivery room
Adverse Hematologic and Cardiovascular Events
number of adverse hematologic/cardiac events
Adverse Hematologic and Respiratory Events
number of adverse hematologic/respiratory events
Adverse Prematurity-Related Events through 36 Weeks Post-Menstrual Age
number of prematurity-related adverse events
Adverse Findings on Late Head Ultrasound
number of adverse findings on the late head ultrasound

Full Information

First Posted
April 14, 2016
Last Updated
March 6, 2023
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
search

1. Study Identification

Unique Protocol Identification Number
NCT02742454
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2016 (undefined)
Primary Completion Date
March 2023 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraventricular Hemorrhage
Keywords
Umbilical Cord Clamping, Intraventricular Hemorrhage, Extremely Preterm Infants

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
940 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard 30-60 Seconds Cord Clamping
Arm Type
Active Comparator
Arm Description
Standard treatment for extremely preterm infants which is delayed cord clamping 30-60 seconds after birth, and assisted ventilation after cord clamping.
Arm Title
VentFirst 120 Seconds Cord Clamping
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
Standard 30-60 Seconds Cord Clamping
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
VentFirst 120 Seconds Cord Clamping
Intervention Description
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 Measure Information:
Title
Intraventricular Hemorrhage on Head Ultrasound
Description
presence of any grade IVH on HUS
Time Frame
7-10 days after birth
Secondary Outcome Measure Information:
Title
Adverse Events in the Delivery Room
Description
number of adverse events in the delivery room
Time Frame
First one hour after birth
Title
Adverse Hematologic and Cardiovascular Events
Description
number of adverse hematologic/cardiac events
Time Frame
First 24 hours after birth
Title
Adverse Hematologic and Respiratory Events
Description
number of adverse hematologic/respiratory events
Time Frame
First 10 days after birth
Title
Adverse Prematurity-Related Events through 36 Weeks Post-Menstrual Age
Description
number of prematurity-related adverse events
Time Frame
Birth through 36 Weeks Post-Menstrual Age
Title
Adverse Findings on Late Head Ultrasound
Description
number of adverse findings on the late head ultrasound
Time Frame
Birth through 36 weeks Post-Menstrual Age

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Fairchild, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045-2571
Country
United States
Facility Name
University of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115-6110
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
St. Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63103-2006
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
37239-0000
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22904-4195
Country
United States
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada
Facility Name
University of Alberta, Edmonton
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs