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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
570
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.
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.
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California, Davis
Sacramento, California, United States
University of Colorado
Denver, Colorado, United States
Intraventricular Hemorrhage on Head Ultrasound or death before 7 days of age
presence of any grade IVH on HUS
Time frame: 7-10 days after birth
5 minute Apgar Score <5
Low Apgar score (\<5) at 5 minutes
Time frame: 5 minutes after birth
Lowest hematocrit in first 24 hours
Median, 25th \& 75th percentiles
Time frame: First 24 hours after birth
Medication for low blood pressure in first 24 hours
Hydrocortisone and/or vasopressor for hypotension
Time frame: First 24 hours after birth
Number of red blood cell transfusions birth through day 10
Median, 25th \& 75th percentiles
Time frame: First 10 days after birth
Severe brain injury on head ultrasound
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
Time frame: Birth through 36 weeks' postmenstrual age
Death
All-cause mortality
Time frame: Birth through 36 weeks' postmenstrual age
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University of Indiana
Indianapolis, Indiana, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
St. Louis University
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Virginia
Charlottesville, Virginia, United States
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