San Diego, California 92123


Purpose:

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.


Study 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. 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.


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 Avulsion - Presence of non-reducible nuchal cord - Perinatal providers unaware of the protocol


NCT ID:

NCT03631940


Primary Contact:

Principal Investigator
Anup Katheria, MD
Sharp HealthCare

Anup C Katheria, MD
Phone: 858-939-4170
Email: anup.katheria@sharp.com


Backup Contact:

Email: katherine.baker@sharp.com
Katherine Baker, RN
Phone: 858-939-4113


Location Contact:

San Diego, California 92123
United States

Anup Katheria, MD
Phone: 858-939-4198
Email: anup.katheria@sharp.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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