PROJECT SUMMARY
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 admission to the NICU. In addition, we believe it may reduce developmental problems in survivors by
two years of age.
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, almost 10 million babies do not
breathe immediately at birth, and about 6 million of these infants need resuscitation. 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. 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 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 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 12 months. Then sites will change to the
other method for an additional 12 months. Parents will be informed about the trial prenatally and invited to join
after birth if their infant qualifies. This trial will involve 620 term newborns needing resuscitation at birth at eight
(8) hospitals in San Diego, CA; La Mesa, CA; Loma Linda, CA; Davis, CA Washington, DC; and Canada. 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.