NCT Number: NCT03631940
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.
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Notify Me35 week–42 week
All sexes
Interventional
Not applicable
University of Alberta, Edmonton, Alberta, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Birth to first 48 hours of life.
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: 12-48 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: Birth to 78 hours of life.
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 through 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: First week of life
Highest single measurement of total serum bilirubin obtained as part of standard care to assess hyperbilirubinemia in neonate.
Time frame: birth to 7 days of life
Highest single measurement of transcutaneous bilirubin obtained as part of standard care to assess hyperbilirubinemia in each neonate.
Time frame: Birth to discharge, assessed up to 180 days of life.
Number of neonatal deaths prior to discharge
Time frame: Birth to discharge, up to 120 days of life.
Number of neonates with a diagnosis of mild, moderate or severe hypoxic ischemic encephalopathy during neonatal intensive care unit admission.
Time frame: birth to discharge, up to 120 days of life.
Number of days neonate was admitted to the neonatal intensive care unit from birth to discharge home.
Time frame: Birth to 48 hours of life.
First single neonatal blood pressure measurement by cuff or arterial line obtained on admission to the neonatal intensive care unit and by 48 hours of life.
Time frame: Birth to first hour of life.
Neonates were assessed for poor tone, poor color (pale, dusky, cyanotic) and poor breathing effort by obstetric provider as part of standard care. Resuscitation assessment and interventions were conducted by neonatal intensive care clinical team. Recorded resuscitation interventions included: use of supplemental oxygen, continuous positive airway pressure respiratory support, positive pressure ventilation respiratory support, endotracheal intubation, chest compressions, epinephrine, normal saline bolus and other cardiorespiratory support medications. Resuscitation interventions including cardiorespiratory support were determined by individual site's clinical standards.
Sharp HealthCare
Other
Acronym: MINVI
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