Clinical trial NCT03631940: Umbilical Cord Milking in Non-Vigorous Infants
Official title: Umbilical Cord Milking in Non-Vigorous Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Birth Asphyxia
Keywords: Umbilical Cord Milking
Immediate Cord Clamping
Resuscitation
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
Collaborators: name: Sharp Mary Birch Hospital for Women & Newborns
name: Sharp Grossmont Hospital
name: University of Utah
name: University of Alberta
name: Poznan University of Medical Sciences
name: IWK Health Centre
name: University of California, Davis
name: Loma Linda University
name: George Washington University
name: Providence Hospital
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-08-15
Enrollment: 1730
Sex: ALL
Minimum age (years): 35
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cluster Randomized Crossover
Primary purpose: PREVENTION

Brief summary: 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 of the umbilical cord at birth for infants who need resuscitation.

Detailed description: 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.

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

Primary outcomes:
measure: Number of Neonatal Participants Admitted to the NICU for Predefined Criteria
timeFrame: Birth to first 48 hours of life.
Secondary outcomes:
measure: Median Neonatal Hemoglobin Between 12 to 48 Hours of Life
timeFrame: 12-48 hours of life
measure: Number of Neonates Treated With Therapeutic Hypothermia ("Cooling")
timeFrame: Birth to 78 hours of life.
measure: Number of Neonates Treated With Normal Saline Bolus in the First 24 Hours of Life
timeFrame: Birth through 24 hours of life
measure: Median Peak Total Serum Bilirubin in Neonates
timeFrame: First week of life
measure: Median Transcutaneous Bilirubin in Neonates
timeFrame: birth to 7 days of life
measure: Number of Neonatal Deaths
timeFrame: Birth to discharge, assessed up to 180 days of life.
Other outcomes:
measure: Number of Neonates Diagnosed With Mild, Moderate or Severe Hypoxic Ischemic Encephalopathy
timeFrame: Birth to discharge, up to 120 days of life.
measure: Median Length of Neonate's Hospitalization in Days Among Participants Discharged Alive
timeFrame: birth to discharge, up to 120 days of life.
measure: Median Neonatal Admission Blood Pressure
timeFrame: Birth to 48 hours of life.
measure: Number of Neonates With Any Cardiorespiratory Support Intervention at Birth
timeFrame: Birth to first hour of life.
Locations:
city: Davis
country: United States
facility: University of California, Davis
state: California
city: Loma Linda
country: United States
facility: Loma Linda Medical Center
state: California
city: San Diego
country: United States
facility: Sharp Grossmont Hospital
state: California
city: San Diego
country: United States
facility: Sharp Mary Birch Hospital for Women and Newborns
state: California
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Salt Lake City
country: United States
facility: University of Utah/IMH
state: Utah
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Dalhousie
country: Canada
facility: Dalhousie University
state: New Brunswick
city: Poznań
country: Poland
facility: Poznan University of Medical Science
Study officials:
affiliation: Sharp HealthCare
name: Anup Katheria, MD
role: PRINCIPAL_INVESTIGATOR
References: