Umbilical Cord Milking in Non-Vigorous Infants



Status:Recruiting
Healthy:No
Age Range:Any
Updated:1/11/2019
Start Date:January 5, 2019
End Date:June 2022
Contact:Anup C Katheria, MD
Email:anup.katheria@sharp.com
Phone:858-939-4170

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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
the umbilical cord at birth for infants who need resuscitation.

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.

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 Avulsion

- Presence of non-reducible nuchal cord

- Perinatal providers unaware of the protocol
We found this trial at
9
sites
Davis, California 95616
Principal Investigator: Mark Underwood, MD
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Akila Subramaniam, MD
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Edmonton, Alberta T6G 2J2
Principal Investigator: Georg Schmoelzer, MD
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Loma Linda, California 92354
Principal Investigator: Giang Truong, MD
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9205 SW Barnes Rd
Portland, Oregon 97225
(503) 216-1234
Providence St. Vincent Medical Center Providence St. Vincent is renowned for its many centers of...
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Salt Lake City, Utah 84113
Principal Investigator: Bradley Yoder, MD
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San Diego, California 92123
Principal Investigator: Yvonne Goff, MD
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San Diego, California 92123
Principal Investigator: Anup Katheria, MD
Phone: 858-939-4198
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Washington, District of Columbia 20052
Principal Investigator: Mayri Leslie, MD
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