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Umbilical Cord Milking in Non-Vigorous Infants (MINVI)

Primary Purpose

Birth Asphyxia

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Umbilical Cord Milking
Early Cord Clamping
Sponsored by
Sharp HealthCare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Birth Asphyxia focused on measuring Umbilical Cord Milking, Immediate Cord Clamping, Resuscitation

Eligibility Criteria

35 Weeks - 42 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, Davis
  • Loma Linda Medical Center
  • Sharp Grossmont Hospital
  • Sharp Mary Birch Hospital for Women and Newborns
  • George Washington University
  • Providence St. Vincent Medical Center
  • University of Utah/IMH
  • University of Alberta
  • Dalhousie University
  • Poznan University of Medical Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Umbilical Cord Milking

Early Cord Clamping

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

NICU Admission
Admission to the Neonatal Intensive Care Unit for Study-specific criteria

Secondary Outcome Measures

Placental Transfusion
Estimated by single hemoglobin measurement
Therapeutic Hypothermia ("Cooling")
Cooling to 33.5 degrees C for 72 hours within the first 6 hours of life
Use of volume expander
Treated with blood products or normal saline bolus to support blood pressure
Hyperbilirubinemia
Total bilirubin per Bhutani nomogram
Death
Death prior to discharge

Full Information

First Posted
August 6, 2018
Last Updated
September 12, 2023
Sponsor
Sharp HealthCare
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)
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1. Study Identification

Unique Protocol Identification Number
NCT03631940
Brief Title
Umbilical Cord Milking in Non-Vigorous Infants
Acronym
MINVI
Official Title
Umbilical Cord Milking in Non-Vigorous Infants
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 5, 2019 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sharp HealthCare
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)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Birth Asphyxia
Keywords
Umbilical Cord Milking, Immediate Cord Clamping, Resuscitation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Cluster Randomized Crossover
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Umbilical Cord Milking
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Early Cord Clamping
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Umbilical Cord Milking
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Early Cord Clamping
Intervention Description
The umbilical cord is clamped within 30 seconds of delivery.
Primary Outcome Measure Information:
Title
NICU Admission
Description
Admission to the Neonatal Intensive Care Unit for Study-specific criteria
Time Frame
Delivery room death or Admission to the NICU in the first 48 hours of life
Secondary Outcome Measure Information:
Title
Placental Transfusion
Description
Estimated by single hemoglobin measurement
Time Frame
12-48 hours of life
Title
Therapeutic Hypothermia ("Cooling")
Description
Cooling to 33.5 degrees C for 72 hours within the first 6 hours of life
Time Frame
72 hours of life
Title
Use of volume expander
Description
Treated with blood products or normal saline bolus to support blood pressure
Time Frame
Through hospital stay, up to 120 days
Title
Hyperbilirubinemia
Description
Total bilirubin per Bhutani nomogram
Time Frame
First week of life
Title
Death
Description
Death prior to discharge
Time Frame
From birth to date of death or discharge, whichever occurs first, assessed up to 180 days
Other Pre-specified Outcome Measures:
Title
Exploratory-Level of Hypoxic Ischemic Encephalopathy
Description
Mild, moderate or severe
Time Frame
Through hospital stay, up to 120 days
Title
Exploratory-Length of Stay
Description
Number of days from birth to discharge home
Time Frame
Through hospital stay, up to 120 days
Title
Exploratory-Blood Pressure
Description
Blood Pressure on Admission to NICU
Time Frame
First 48 hours of life
Title
Exploratory-Resuscitation interventions
Description
Level of resuscitation interventions at delivery
Time Frame
First hour of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Weeks
Maximum Age & Unit of Time
42 Weeks
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anup Katheria, MD
Organizational Affiliation
Sharp HealthCare
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
Facility Name
Loma Linda Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Facility Name
Sharp Grossmont Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Sharp Mary Birch Hospital for Women and Newborns
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20052
Country
United States
Facility Name
Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225-6603
Country
United States
Facility Name
University of Utah/IMH
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2R3
Country
Canada
Facility Name
Dalhousie University
City
Dalhousie
State/Province
New Brunswick
ZIP/Postal Code
E8C 2R6
Country
Canada
Facility Name
Poznan University of Medical Science
City
Poznań
Country
Poland

12. IPD Sharing Statement

Links:
URL
http://clinicaltrials.gov/ct2/show/NCT03621956
Description
MINVI NIRS Substudy
URL
https://clinicaltrials.gov/ct2/show/NCT03621943
Description
MINVI Follow-up study
URL
https://clinicaltrials.gov/ct2/show/NCT03798093
Description
MINVI Echocardiogram Substudy

Learn more about this trial

Umbilical Cord Milking in Non-Vigorous Infants

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