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Trial record 23 of 31 for:    Developmental Disabilities | ( Map: Alabama, United States )

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

Tracking Information
First Submitted Date  ICMJE August 6, 2018
First Posted Date  ICMJE August 9, 2018
Last Update Posted Date August 10, 2018
Estimated Study Start Date  ICMJE June 2020
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2018)
Neurodevelopmental Outcome at 2 Years of Age [ Time Frame: 22-26 months ]
Overall and Domain Scores - Ages and Stages, 3rd ed. Questionnaire
Original Primary Outcome Measures  ICMJE
 (submitted: August 6, 2018)
Neurodevelopmental Outcome at 2 Years of Age [ Time Frame: 22-26 mos. ]
Overall and Domain Scores - Ages and Stages, 3rd ed. Questionnaire
Change History Complete list of historical versions of study NCT03621943 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2018)
Autism Outcome [ Time Frame: 22-26 months ]
Modified Checklist for Autism in Toddlers (M-CHAT-R)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2018)
Autism Outcome [ Time Frame: 22-26 mos ]
Modified Checklist for Autism in Toddlers (M-CHAT-R)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Umbilical Cord Milking in Non-Vigorous Infants Developmental Followup (MINVIFU)
Official Title  ICMJE Umbilical Cord Milking in Non-Vigorous Infants Developmental Followup (MINVIFU)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Neurodevelopmental Abnormality
Intervention  ICMJE
  • 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.
  • Procedure: Early Cord Clamping
    The umbilical cord is clamped within 30 seconds of delivery.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Umbilical Cord Milking
  • Active Comparator: Early Cord Clamping
    The umbilical cord is clamped within 30 seconds of delivery.
    Intervention: Procedure: Early Cord Clamping
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 6, 2018)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Months to 26 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anup Katheria 8589001219 anup.katheria@sharp.com
Contact: Katherine Baker, RN 858 939 4113 katherine.baker@sharp.com
Listed Location Countries  ICMJE United States,   Canada,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03621943
Other Study ID Numbers  ICMJE MINVIFU
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Anup Katheria, M.D., Sharp HealthCare
Study Sponsor  ICMJE Sharp HealthCare
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sharp HealthCare
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP