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Umbilical Cord Milking in Non-Vigorous Infants (MINVI)

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ClinicalTrials.gov Identifier: NCT03631940
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : November 19, 2019
Sponsor:
Collaborators:
Sharp Mary Birch Hospital for Women & Newborns
Sharp Grossmont Hospital
University of Utah
University of Alberta
Poznan University of Medical Sciences
IWK Health Centre
University of California, Davis
Loma Linda University
George Washington University
Providence Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Anup Katheria, M.D., Sharp HealthCare

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.

Condition or disease Intervention/treatment Phase
Birth Asphyxia Procedure: Umbilical Cord Milking Procedure: Early Cord Clamping Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Cluster Randomized Crossover
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Umbilical Cord Milking in Non-Vigorous Infants
Actual Study Start Date : January 5, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Umbilical Cord Milking
The delivering practitioner will place the newborn below the level of the incision (at the edge of the table) at C/S and a second team member will milk the cord four times. For vaginal delivery, the delivering obstetrician, midwife or perinatal provider will hold the infant against their body or place the infant on the mother's abdomen and the cord will be milked either four times by the obstetrical provider or by a second team member. For the cord milking procedure, the obstetrical provider will milk the entire length of umbilical cord over two seconds, repeating three additional times as described previously. This time is not significantly different from the time for ECC as we have demonstrated in our previous trials.
Procedure: Umbilical Cord Milking
At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 15-20 seconds.

Active Comparator: Early Cord Clamping
This will occur by clamping the umbilical cord as soon as possible. Since both ECC and UCM will occur after a brief assessment, it is important to note that the cord clamping time will be longer than in previously conducted preterm trials (average 20 seconds) which performed the intervention on all subjects regardless of whether or not they were vigorous. In all cases, the cord clamping time will be documented to ensure consistency.
Procedure: Early Cord Clamping
The umbilical cord is clamped within 30 seconds of delivery.




Primary Outcome Measures :
  1. NICU Admission [ Time Frame: Delivery room death or Admission to the NICU in the first 48 hours of life ]
    Admission to the Neonatal Intensive Care Unit for Study-specific criteria


Secondary Outcome Measures :
  1. Placental Transfusion [ Time Frame: 12-48 hours of life ]
    Estimated by single hemoglobin measurement

  2. Therapeutic Hypothermia ("Cooling") [ Time Frame: 72 hours of life ]
    Cooling to 33.5 degrees C for 72 hours within the first 6 hours of life

  3. Use of volume expander [ Time Frame: Through hospital stay, up to 120 days ]
    Treated with blood products or normal saline bolus to support blood pressure

  4. Hyperbilirubinemia [ Time Frame: First week of life ]
    Total bilirubin per Bhutani nomogram

  5. Death [ Time Frame: From birth to date of death or discharge, whichever occurs first, assessed up to 180 days ]
    Death prior to discharge


Other Outcome Measures:
  1. Exploratory-Level of Hypoxic Ischemic Encephalopathy [ Time Frame: Through hospital stay, up to 120 days ]
    Mild, moderate or severe

  2. Exploratory-Length of Stay [ Time Frame: Through hospital stay, up to 120 days ]
    Number of days from birth to discharge home

  3. Exploratory-Blood Pressure [ Time Frame: First 48 hours of life ]
    Blood Pressure on Admission to NICU

  4. Exploratory-Resuscitation interventions [ Time Frame: First hour of life ]
    Level of resuscitation interventions at delivery



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Weeks to 42 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03631940


Contacts
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Contact: Anup C Katheria, MD 858-939-4170 anup.katheria@sharp.com
Contact: Katherine Baker, RN 858-939-4113 katherine.baker@sharp.com

Locations
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United States, California
University of California, Davis Recruiting
Davis, California, United States, 95616
Contact: Mark Underwood, MD       munderwood@ucdavis.edu   
Principal Investigator: Mark Underwood, MD         
Principal Investigator: Deb Wright, MD         
Principal Investigator: Satyanarayana Lakshminrusimha, MD         
Loma Linda Medical Center Recruiting
Loma Linda, California, United States, 92350
Contact: Farha Vora, MD       FVora@llu.edu   
Contact: Courtney Martin, MD       COUMartin@llu.edu   
Principal Investigator: Farha Vora, MD         
Principal Investigator: Courtney Martin, MD         
Sharp Grossmont Hospital Recruiting
San Diego, California, United States, 91942
Contact: Katherine Baker, RN       katherine.baker@sharp.com   
Contact: Felix Ines, RRT       felix.ines@sharp.com   
Principal Investigator: Yvonne Goff, MD         
Principal Investigator: Kevin Fulford, MD         
Sharp Mary Birch Hospital for Women and Newborns Recruiting
San Diego, California, United States, 92123
Contact: Anup Katheria, MD    858-939-4198    anup.katheria@sharp.com   
Contact: Katherine Baker, RN    858 939 4113    katherine.baker@sharp.com   
Principal Investigator: Anup Katheria, MD         
United States, District of Columbia
George Washington University Recruiting
Washington, District of Columbia, United States, 20052
Contact: Mohamed Mohamed, MD       mmohamed@mfa.gwu.edu   
Principal Investigator: Mayri Leslie, MD         
Principal Investigator: Mohamed Mohamed, MD         
Principal Investigator: Shetal Sheth, MD         
United States, Oregon
Providence St. Vincent Medical Center Recruiting
Portland, Oregon, United States, 97225-6603
Contact: Joseph Kaempf, MD       Joseph.Kaempf@providence.org   
Contact: Mark Tomlinson, MD       Mark.Tomlinson@providence.org   
United States, Utah
University of Utah/IMH Recruiting
Salt Lake City, Utah, United States, 84113
Principal Investigator: Bradley Yoder, MD         
Principal Investigator: Erin Clark, MD         
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2R3
Contact: Georg Schmoelzer, MD       gschmoelzer@me.com   
Principal Investigator: Georg Schmoelzer, MD         
Principal Investigator: Radha Chari, MD         
Canada, New Brunswick
Dalhousie University Recruiting
Dalhousie, New Brunswick, Canada, E8C 2R6
Contact: Walid El-Naggar, MD       walid.el-naggar@iwk.nshealth.ca   
Principal Investigator: Walid El-Naggar, MD         
Principal Investigator: David Rittenberg, MD         
Poland
Poznan University of Medical Science Recruiting
Poznań, Poland
Contact: Agnieszka Basiukajc, MD       aga_basiukajc90@wp.pl   
Contact: Jan Mazela, MD, PhD       janco@pol-med.com.pl   
Sponsors and Collaborators
Sharp HealthCare
Sharp Mary Birch Hospital for Women & Newborns
Sharp Grossmont Hospital
University of Utah
University of Alberta
Poznan University of Medical Sciences
IWK Health Centre
University of California, Davis
Loma Linda University
George Washington University
Providence Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Anup Katheria, MD Sharp HealthCare

Additional Information:
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Responsible Party: Anup Katheria, M.D., Director, Neonatal Research Institute, Sharp HealthCare
ClinicalTrials.gov Identifier: NCT03631940     History of Changes
Other Study ID Numbers: MINVI
5R01HD096023-02 ( U.S. NIH Grant/Contract )
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anup Katheria, M.D., Sharp HealthCare:
Umbilical Cord Milking
Immediate Cord Clamping
Resuscitation
Additional relevant MeSH terms:
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Asphyxia Neonatorum
Asphyxia
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases