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

Not Applicable

Active, not recruiting

• Conditions: Intraventricular Hemorrhage
• Interventions: Procedure: Standard 30-60 Seconds Cord Clamping; Procedure: VentFirst 120 Seconds Cord Clamping

• Registration Number: NCT02742454
• Lead Sponsor: University of Virginia

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

Newborns with gestational age 23 wks 0 days through 28 wks 6 days are randomized to control (delayed cord clamping for at least 30 seconds, or up to 60 seconds if breathing spontaneously, with ventilatory assistance provided after) or the VentFirst intervention (ventilatory assistance with continuous positive airway pressure or positive pressure ventilation given starting 30 seconds after birth and cord clamping at 120 seconds).

The primary outcome is lack of IVH on 7-10 day head ultrasound or death before day 7.

The study was designed to test the impact of the intervention in each of two cohorts:

1. Infants not breathing well 30 seconds after birth

2. Infants breathing well 30 seconds after birth

Randomization and analysis is stratified by gestational age category:

1. 23 0/6 to 25 6/7 weeks' gestation

2. 26 0/7 to 28 6/7 weeks' gestation

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-04-14
• Study First Submitted QC: 2016-04-18
• Study First Posted: 2016-04-19
• Study Start: 2016-06
• Primary Completion: 2023-03
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-25
• Last Update Posted: 2023-10-30
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 570

Inclusion Criteria

• 23 0/7 - 28 6/7 weeks' gestation at delivery

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard 30-60 Seconds Cord Clamping	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.
VentFirst 120 Seconds Cord Clamping	VentFirst 120 Seconds Cord Clamping	Assisted ventilation (face mask continuous positive airway pressure, CPAP, or positive pressure ventilation, PPV) is provided prior to cord clamping at 120 seconds.

Primary Outcome Measures

Name	Time	Method
Intraventricular Hemorrhage on Head Ultrasound or death before 7 days of age	7-10 days after birth	presence of any grade IVH on HUS

Secondary Outcome Measures

Name	Time	Method
5 minute Apgar Score <5	5 minutes after birth	Low Apgar score (\<5) at 5 minutes
Severe brain injury on head ultrasound	Birth through 36 weeks' postmenstrual age	Grade 3-4 IVH and/or cerebellar hemorrhage and/or cystic periventricular leukomalacia on head ultrasound at 7-10 days of age and/or near 36 weeks' postmenstrual age
Death	Birth through 36 weeks' postmenstrual age	All-cause mortality
Lowest hematocrit in first 24 hours	First 24 hours after birth	Median, 25th \& 75th percentiles
Medication for low blood pressure in first 24 hours	First 24 hours after birth	Hydrocortisone and/or vasopressor for hypotension
Number of red blood cell transfusions birth through day 10	First 10 days after birth	Median, 25th \& 75th percentiles

Trial Locations

Locations (12)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

St. Louis University; 🇺🇸 Saint Louis, Missouri, United States

University of Alberta, Edmonton; 🇨🇦 Edmonton, Alberta, Canada

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of California, Davis; 🇺🇸 Sacramento, California, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Colorado; 🇺🇸 Denver, Colorado, United States

University of Indiana; 🇺🇸 Indianapolis, Indiana, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States