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

Neurodevelopmental Abnormality Clinical Trial

— MINVIFU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03621943
• Other study ID #: MINVIFU
• Status: Completed
• Phase: N/A
• Start date: January 7, 2019
• Est. completion date: September 26, 2023

Study information

• Verified date: December 2023
• Source: Sharp HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1207
• Est. completion date: September 26, 2023
• Est. primary completion date: June 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Months to 26 Months

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Neurodevelopmental Abnormality

Intervention

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.
• Early Cord Clamping
The umbilical cord is clamped within 30 seconds of delivery.

Locations

Country	Name	City	State
Canada	Dalhousie University	Dalhousie	New Brunswick
Canada	University of Alberta	Edmonton	Alberta
Poland	Poznan University of Medical Science	Poznan
United States	University of California, Davis	Davis	California
United States	Loma Linda Medical Center	Loma Linda	California
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	University of Utah/IMH	Salt Lake City	Utah
United States	Sharp Grossmont Hospital	San Diego	California
United States	Sharp Mary Birch Hospital for Women and Newborns	San Diego	California
United States	George Washington University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Sharp HealthCare

Countries where clinical trial is conducted

United States,  Canada,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurodevelopmental Outcome at 2 Years of Age	Overall and Domain Scores - Ages and Stages, 3rd ed. Questionnaire	22-26 months
Secondary	Autism Outcome	Modified Checklist for Autism in Toddlers (M-CHAT-R)	22-26 months