A Cluster Randomized Clinical Trial of Umbilical Cord Milking to Improve Short and Long-term Outcomes in Neonates Who are Non-Vigorous at Birth

PROJECT SUMMARY
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. Worldwide each year, 10 million babies do not breathe immediately
at birth, and approximately one million babies die annually in low and middle-income countries due to a brain
injury caused by inadequate blood flow and oxygen delivery to the neonatal brain, a condition known as hypoxic
ischemic encephalopathy (HIE). The usual 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. We propose a
study to see if umbilical cord milking (UCM) for those infants who need resuscitation is better than immediately
clamping and cutting the umbilical cord at birth. We wonder if it will reduce death and/or HIE. In addition, it may
reduce developmental problems in survivors by two years of age. 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 fromaround the world have identified that infants
needing resuscitation are more likely to die or develop conditions such as cerebral palsy, autism and other
developmental problems. The large amount of fetal blood left in the placenta after immediate cord clamping
means that the baby gets less blood for the brain, lungs, and heart, which can contribute, to brain injury and
even death. Cord milking at birth may help to protect these infants by increasing the transfer of blood volume.
Our prior work has shown that, compared to immediate cord clamping, UCM results in better heart rate, blood
pressure, less early anemia, and more oxygen in the brain. No harm from UCM has been noted in term infants
in any studies.
We will use a design in which each hospital will be randomly assigned to use either immediate cord clamping or
UCM for any infant needing resuscitation over a period of 6 months. Then sites will change to the other method
for an additional 6 months. This trial will involve 3442 term newborns who are depressed at birth at seven (7)
hospitals in India. This trial will provide evidence to promote a change in guidelines supporting the use of UCM
– a simple, no-cost intervention as standard of care in term and near-term newborns needing resuscitation.

Grant Number: 5R01HD102967-04
NIH Institute/Center: NIH
Principal Investigator: ZUBAIR AGHAI