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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 : Not yet recruiting
First Posted : August 9, 2018
Last Update Posted : August 10, 2018
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)
Estimated Study Start Date : June 2020
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, Alabama
University of Alabama-Birmingham
Birmingham, Alabama, United States, 35294-0004
United States, California
University of California, Davis
Davis, California, United States, 95616
Loma Linda Medical Center
Loma Linda, California, United States, 92350
Sharp Grossmont Hospital
San Diego, California, United States, 91942
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, United States, 92123
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20052
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2R3
Canada, New Brunswick
Dalhousie University
Dalhousie, New Brunswick, Canada, E8C 2R6
Germany
University of Ulm
Ulm, Germany, 89081
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: August 10, 2018
Last Verified: August 2018
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