The investigators will conduct a study of non-vigorous term infants to determine if umbilical cord milking (UCM) results in a lower rate of NICU admissions than early clamping and cutting of the umbilical cord at birth for infants who need resuscitation.
At birth, it is critical that an infant begins breathing quickly. The infant has to switch from relying on the placenta for oxygen to using its lungs for the first time. The currently recommended practice for infants who need resuscitation is to immediately clamp the umbilical cord. Animal studies show that clamping the cord before the baby breathes can cause the heart beat to slow and can decrease the amount of blood being pumped out of the heart each minute. This study will test whether infants will benefit from UCM. The cord will be quickly milked four times before cutting and will not delay the resuscitation procedures. This study is important because when there is need for resuscitation, neither UCM or delayed cord clamping, are recommended by national and international organizations due to lack of evidence. Yet, several large studies from around the world have identified that infants needing resuscitation are more likely to develop conditions such as cerebral palsy, autism and other developmental problems. The trial is a cluster crossover design in which each hospital will be randomly assigned to use either early cord clamping or UCM for any infant needing resuscitation over a period of 12 months. Then sites will change to the other method for an additional 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,730
At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 15-20 seconds.
The umbilical cord is clamped within 60 seconds of delivery.
University of California, Davis
Davis, California, United States
Loma Linda Medical Center
Loma Linda, California, United States
Sharp Grossmont Hospital
San Diego, California, United States
Number of Neonatal Participants Admitted to the NICU for Predefined Criteria
Number of neonatal participants admitted to the neonatal intensive care unit for study-specific predefined criteria including respiratory distress, oxygen desaturation, hypoglycemia, hypotonia, apnea, lethargy or difficulty arousing, hypertonia or irritability, temperature instability, bradycardia or tachycardia, seizures or seizure-like activity, poor feeding or emesis, hyperbilirubinemia, death before NICU admission.
Time frame: Birth to first 48 hours of life.
Median Neonatal Hemoglobin Between 12 to 48 Hours of Life
Single hemoglobin measurement for the neonate which was obtained between 12 to 48 hours of life collected with written consent or as part of standard care.
Time frame: 12-48 hours of life
Number of Neonates Treated With Therapeutic Hypothermia ("Cooling")
Number of neonates that were treated with therapeutic hypothermia (Cooling to 33.5 degrees Celsius) for 72 hours and initiated within the first 6 hours of life.
Time frame: Birth to 78 hours of life.
Number of Neonates Treated With Normal Saline Bolus in the First 24 Hours of Life
Number of neonates treated with normal saline bolus in the first 24 hours of life to support blood pressure.
Time frame: Birth through 24 hours of life
Median Peak Total Serum Bilirubin in Neonates
Highest single measurement of total serum bilirubin obtained as part of standard care to assess hyperbilirubinemia in neonate.
Time frame: First week of life
Median Transcutaneous Bilirubin in Neonates
Highest single measurement of transcutaneous bilirubin obtained as part of standard care to assess hyperbilirubinemia in each neonate.
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Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, United States
George Washington University
Washington D.C., District of Columbia, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
University of Utah/IMH
Salt Lake City, Utah, United States
University of Alberta
Edmonton, Alberta, Canada
Dalhousie University
Dalhousie, New Brunswick, Canada
Poznan University of Medical Science
Poznan, Poland
Time frame: birth to 7 days of life
Number of Neonatal Deaths
Number of neonatal deaths prior to discharge
Time frame: Birth to discharge, assessed up to 180 days of life.