Back to resultsUmbilical Cord Milking in Non-Vigorous Infants Developmental Followup (MINVIFU) (MINVIFU)
Primary Purpose
Neurodevelopmental Abnormality
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Umbilical Cord Milking
Early Cord Clamping
Sponsored by
About this trial
This is an interventional diagnostic trial for Neurodevelopmental Abnormality focused on measuring Neurodevelopmental impairment, Disability, Umbilical cord milking, Early Cord Clamping
Eligibility Criteria
Inclusion Criteria:
- Enrolled in MINVI trial who survive to 2 years corrected age
Exclusion Criteria:
- Enrolled in MINVI but did not survive to 2 years.
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
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.
The umbilical cord is clamped within 30 seconds of delivery.
Outcomes
Primary Outcome Measures
Neurodevelopmental Outcome at 2 Years of Age
Overall and Domain Scores - Ages and Stages, 3rd ed. Questionnaire
Secondary Outcome Measures
Autism Outcome
Modified Checklist for Autism in Toddlers (M-CHAT-R)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03621943
Brief Title
Umbilical Cord Milking in Non-Vigorous Infants Developmental Followup (MINVIFU)
Acronym
MINVIFU
Official Title
Umbilical Cord Milking in Non-Vigorous Infants Developmental Followup (MINVIFU)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
June 2, 2021 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sharp HealthCare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
An extension of the MINVI trial, the MINVI Follow-Up trial will evaluate the neurodevelopmental outcomes at 22-26 months corrected age of term/near term infants who received UCM or ECC.
Detailed Description
The MINVI Follow-up trial will examine the difference in early childhood neurodevelopmental impairment of subjects enrolled in the MINVI trial using standardized neurological and developmental assessments at 22-26 months corrected age.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurodevelopmental Abnormality
Keywords
Neurodevelopmental impairment, Disability, Umbilical cord milking, Early Cord Clamping
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Neurodevelopmental assessments will be done at 2 years of corrected age (22-26 months) for subjects who were randomized to receive either early cord clamping or umbilical cord milking as part of the MINVI trial.
Masking
Outcomes Assessor
Masking Description
Neurodevelopmental providers will be blinded to the randomization of the toddler during the examination.
Allocation
Randomized
Enrollment
1207 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Umbilical Cord Milking
Arm Type
Active Comparator
Arm 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.
Arm Title
Early Cord Clamping
Arm Type
Active Comparator
Arm Description
The umbilical cord is clamped within 30 seconds of delivery.
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
Neurodevelopmental Outcome at 2 Years of Age
Description
Overall and Domain Scores - Ages and Stages, 3rd ed. Questionnaire
Time Frame
22-26 months
Secondary Outcome Measure Information:
Title
Autism Outcome
Description
Modified Checklist for Autism in Toddlers (M-CHAT-R)
Time Frame
22-26 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Months
Maximum Age & Unit of Time
26 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Enrolled in MINVI trial who survive to 2 years corrected age
Exclusion Criteria:
Enrolled in MINVI but did not survive to 2 years.
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
Plan to Share IPD
No
Learn more about this trial
Umbilical Cord Milking in Non-Vigorous Infants Developmental Followup (MINVIFU)
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