Umbilical Cord Milking in Non-Vigorous Infants
- Conditions
- Birth Asphyxia
- Interventions
- Procedure: Umbilical Cord MilkingProcedure: Early Cord Clamping
- Registration Number
- NCT03631940
- Lead Sponsor
- Sharp HealthCare
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1730
- Non-vigorous newborns born between 35-42 weeks gestation
- Known major congenital or chromosomal anomalies of newborn
- Known cardiac defects other than small ASD, VSD and PDA
- Complete placental abruption/cutting through the placenta at time of delivery
- Monochorionic multiples
- Cord anomaly (i.e. cord avulsion, true knot)
- Presence of non-reducible nuchal cord
- Perinatal providers unaware of the protocol
- Incomplete delivery data
- Infants born in extremis, for whom additional treatment will not be offered
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Umbilical Cord Milking Umbilical Cord Milking The delivering practitioner will place the newborn below the level of the incision (at the edge of the table) at C/S and a second team member will milk the cord four times. For vaginal delivery, the delivering obstetrician, midwife or perinatal provider will hold the infant against their body or place the infant on the mother's abdomen and the cord will be milked either four times by the obstetrical provider or by a second team member. For the cord milking procedure, the obstetrical provider will milk the entire length of umbilical cord over two seconds, repeating three additional times as described previously. This time is not significantly different from the time for ECC as we have demonstrated in our previous trials. Early Cord Clamping Early Cord Clamping This will occur by clamping the umbilical cord as soon as possible. Since both ECC and UCM will occur after a brief assessment, it is important to note that the cord clamping time will be longer than in previously conducted preterm trials (average 20 seconds) which performed the intervention on all subjects regardless of whether or not they were vigorous. In all cases, the cord clamping time will be documented to ensure consistency.
- Primary Outcome Measures
Name Time Method Number of Neonatal Participants Admitted to the NICU for Predefined Criteria 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.
- Secondary Outcome Measures
Name Time Method Median Neonatal Hemoglobin Between 12 to 48 Hours of Life 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.
Number of Neonates Treated With Therapeutic Hypothermia ("Cooling") 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.
Number of Neonates Treated With Normal Saline Bolus in the First 24 Hours of Life 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.
Median Peak Total Serum Bilirubin in Neonates First week of life Highest single measurement of total serum bilirubin obtained as part of standard care to assess hyperbilirubinemia in neonate.
Median Transcutaneous Bilirubin in Neonates birth to 7 days of life Highest single measurement of transcutaneous bilirubin obtained as part of standard care to assess hyperbilirubinemia in each neonate.
Number of Neonatal Deaths Birth to discharge, assessed up to 180 days of life. Number of neonatal deaths prior to discharge
Trial Locations
- Locations (10)
Loma Linda Medical Center
πΊπΈLoma Linda, California, United States
Sharp Grossmont Hospital
πΊπΈSan Diego, California, United States
Sharp Mary Birch Hospital for Women and Newborns
πΊπΈSan Diego, California, United States
University of Alberta
π¨π¦Edmonton, Alberta, Canada
Dalhousie University
π¨π¦Dalhousie, New Brunswick, Canada
Providence St. Vincent Medical Center
πΊπΈPortland, Oregon, United States
University of Utah/IMH
πΊπΈSalt Lake City, Utah, United States
George Washington University
πΊπΈWashington, District of Columbia, United States
Poznan University of Medical Science
π΅π±PoznaΕ, Poland
University of California, Davis
πΊπΈDavis, California, United States