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

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.

Conditions

• Intraventricular Hemorrhage

Interventions

PROCEDURE

Standard 30-60 Seconds Cord Clamping

The infant is stimulated to breathe after birth. If the infant is not breathing well, the cord is clamped at 30 seconds. If the baby is breathing well, the cord is clamped at 60 seconds. Ventilatory assistance is given after cord clamping.

PROCEDURE

VentFirst 120 Seconds Cord Clamping

The infant is stimulated to breathe after birth. If the infant is not breathing well, PPV by face mask is given starting at 30 seconds. If the baby is breathing well, CPAP is given starting at 30 seconds. The cord is clamped at 120 seconds.

Sponsors & Collaborators

• Brigham and Women's Hospital

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• St. Louis University

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• Oregon Health and Science University

  collaborator OTHER

• University of Calgary

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Indiana University

  collaborator OTHER

• University of California, Davis

  collaborator OTHER

• University of Alberta

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• University of Virginia

  lead OTHER

Principal Investigators

• Karen Fairchild, MD · University of Virginia

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-06-30

Primary Completion

2023-03-31

Completion

2023-12-31

Countries

• United States
• Canada

Study Locations