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Umbilical Cord Milking in Non-Vigorous Infants Developmental Followup (MINVIFU) (MINVIFU)

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ClinicalTrials.gov Identifier: NCT03621943
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Anup Katheria, M.D., Sharp HealthCare

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Outcomes Assessor)
Masking Description: Neurodevelopmental providers will be blinded to the randomization of the toddler during the examination.
Primary Purpose: Diagnostic
Official Title: Umbilical Cord Milking in Non-Vigorous Infants Developmental Followup (MINVIFU)
Actual Study Start Date : January 7, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Arm Intervention/treatment
Active Comparator: 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.
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
The umbilical cord is clamped within 30 seconds of delivery.
Procedure: Early Cord Clamping
The umbilical cord is clamped within 30 seconds of delivery.




Primary Outcome Measures :
  1. Neurodevelopmental Outcome at 2 Years of Age [ Time Frame: 22-26 months ]
    Overall and Domain Scores - Ages and Stages, 3rd ed. Questionnaire


Secondary Outcome Measures :
  1. Autism Outcome [ Time Frame: 22-26 months ]
    Modified Checklist for Autism in Toddlers (M-CHAT-R)



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Ages Eligible for Study:   22 Months to 26 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT03621943


Contacts
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Contact: Anup Katheria 8589001219 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: Giang Truong, MD       GTTruong@llu.edu   
Principal Investigator: Giang Truong, MD         
Sharp Grossmont Hospital Recruiting
San Diego, California, United States, 91942
Contact: Katherine Baker, RN       katherine.baker@sharp.com   
Contact: Felix Inez, RRT       felix.inez@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: Kathy Arnell, RN    858 939 4966    kathy.arnell@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         
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   
Principal Investigator: Joseph Kaempf, MD         
Principal Investigator: Mark Tomlinson, MD         
United States, Utah
University of Utah/IMH Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Bradley Yoder, MD         
Contact: Erin Clark, MD         
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       georg.schmoelzer@me.com   
Contact: Radha Chari, MD       radha.chari@albertahealthservices.ca   
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   
Principal Investigator: Agnieszka Basiukajc, MD         
Principal Investigator: Jan Mazela, MD, PhD         
Sponsors and Collaborators
Sharp HealthCare

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Responsible Party: Anup Katheria, M.D., Director, Neonatal Research Institute, Sharp HealthCare
ClinicalTrials.gov Identifier: NCT03621943     History of Changes
Other Study ID Numbers: MINVIFU
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Neurodevelopmental impairment
Disability
Umbilical cord milking
Early Cord Clamping
Additional relevant MeSH terms:
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Congenital Abnormalities