NCT02742454

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
570

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
2 countries

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

6.8 years

First QC Date

April 14, 2016

Last Update Submit

October 25, 2023

Conditions

Intraventricular Hemorrhage

Keywords

Umbilical Cord ClampingIntraventricular HemorrhageExtremely Preterm Infants

Outcome Measures

Primary Outcomes (1)

  • Intraventricular Hemorrhage on Head Ultrasound or death before 7 days of age

    presence of any grade IVH on HUS

    7-10 days after birth

Secondary Outcomes (6)

  • 5 minute Apgar Score <5

    5 minutes after birth

  • Lowest hematocrit in first 24 hours

    First 24 hours after birth

  • Medication for low blood pressure in first 24 hours

    First 24 hours after birth

  • Number of red blood cell transfusions birth through day 10

    First 10 days after birth

  • Severe brain injury on head ultrasound

    Birth through 36 weeks' postmenstrual age

  • +1 more secondary outcomes

Other Outcomes (31)

  • Maternal post-partum hemorrhage

    First 24 hours after delivery

  • Maternal red blood cell transfusion

    Prior to maternal hospital discharge

  • Maternal retained placenta

    Prior to hospital discharge

  • +28 more other outcomes

Study Arms (2)

Standard 30-60 Seconds Cord Clamping

ACTIVE COMPARATOR

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

VentFirst 120 Seconds Cord Clamping

EXPERIMENTAL

Assisted ventilation (face mask continuous positive airway pressure, CPAP, or positive pressure ventilation, PPV) is provided prior to cord clamping at 120 seconds.

Procedure: VentFirst 120 Seconds Cord Clamping

Interventions

Standard 30-60 Seconds Cord ClampingPROCEDURE

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.

Standard 30-60 Seconds Cord Clamping
VentFirst 120 Seconds Cord ClampingPROCEDURE

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.

VentFirst 120 Seconds Cord Clamping

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • /7 - 28 6/7 weeks' gestation at delivery

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of California, Davis

Sacramento, California, 95817, United States

Location

University of Colorado

Denver, Colorado, 80045-2571, United States

Location

University of Indiana

Indianapolis, Indiana, 46202, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115-6110, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905-0001, United States

Location

St. Louis University

St Louis, Missouri, 63103-2006, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Oregon Health & Science University

Portland, Oregon, 37239-0000, United States

Location

University of Virginia

Charlottesville, Virginia, 22904-4195, United States

Location

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

University of Alberta, Edmonton

Edmonton, Alberta, T5H 3V9, Canada

Location

Related Publications (2)

  • Fang JL, Fairchild KD, Petroni GR, Strand ML, Warren JB, Law BH, Gorman TE, Leone TA, Thomas SP, Niermeyer S; VentFirst Consortium. Physiologic Transition During Delayed Cord Clamping With Assisted Ventilation in Preterm Infants: A Secondary Analysis of the VentFirst Trial. JAMA Netw Open. 2025 Nov 3;8(11):e2545258. doi: 10.1001/jamanetworkopen.2025.45258.

    PMID: 41284295DERIVED

  • Fairchild KD, Petroni GR, Varhegyi NE, Strand ML, Josephsen JB, Niermeyer S, Barry JS, Warren JB, Rincon M, Fang JL, Thomas SP, Travers CP, Kane AF, Carlo WA, Byrne BJ, Underwood MA, Poulain FR, Law BH, Gorman TE, Leone TA, Bulas DI, Epelman M, Kline-Fath BM, Chisholm CA, Kattwinkel J; VentFirst Consortium. Ventilatory Assistance Before Umbilical Cord Clamping in Extremely Preterm Infants: A Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e2411140. doi: 10.1001/jamanetworkopen.2024.11140.

    PMID: 38758557DERIVED

Study Officials

  • Karen Fairchild, MD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Board-certified radiologists interpreting head ultrasound findings are blinded to study arm. Consensus on maximum grade of IVH between two radiologists (some combination of site radiologist and one of three external readers blinded to each others' interpretation) is required.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

April 14, 2016

First Posted

April 19, 2016

Study Start

June 1, 2016

Primary Completion

March 1, 2023

Study Completion

December 1, 2023

Last Updated

October 30, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)US(10)