Umbilical Cord Milking in Non-Vigorous Infants (MINVI)
Birth Asphyxia
About this trial
This is an interventional prevention trial for Birth Asphyxia focused on measuring Umbilical Cord Milking, Immediate Cord Clamping, Resuscitation
Eligibility Criteria
Inclusion Criteria:
- Non-vigorous newborns born between 35-42 weeks gestation
Exclusion Criteria:
- 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
Sites / Locations
- University of California, Davis
- Loma Linda Medical Center
- Sharp Grossmont Hospital
- Sharp Mary Birch Hospital for Women and Newborns
- George Washington University
- Providence St. Vincent Medical Center
- University of Utah/IMH
- University of Alberta
- Dalhousie University
- Poznan University of Medical Science
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Umbilical Cord Milking
Early Cord Clamping
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.
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.