VentFirst: A Multicenter RCT of Assisted Ventilation During Delayed Cord Clamping for Extremely Preterm Infants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intraventricular Hemorrhage
- Sponsor
- University of Virginia
- Enrollment
- 570
- Locations
- 12
- Primary Endpoint
- Intraventricular Hemorrhage on Head Ultrasound or death before 7 days of age
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
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
Investigators
Karen Fairchild, MD
Professor of Pediatrics
University of Virginia
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.
Outcomes
Primary Outcomes
Intraventricular Hemorrhage on Head Ultrasound or death before 7 days of age
Time Frame: 7-10 days after birth
presence of any grade IVH on HUS
Secondary Outcomes
- 5 minute Apgar Score <5(5 minutes after birth)
- Severe brain injury on head ultrasound(Birth through 36 weeks' postmenstrual age)
- Death(Birth through 36 weeks' postmenstrual age)
- 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)