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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neurodevelopmental Abnormality

Intervention / Treatment
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* Procedure: Umbilical Cord Milking
* Procedure: Early Cord Clamping


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Months
Maximum Age: 26 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Umbilical Cord Milking<br>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<br>* 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.<br>|
| Active Comparator: Early Cord Clamping<br>The umbilical cord is clamped within 30 seconds of delivery. | Procedure: Early Cord Clamping<br>* The umbilical cord is clamped within 30 seconds of delivery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurodevelopmental Outcome at 2 Years of Age | Overall and Domain Scores - Ages and Stages, 3rd ed. Questionnaire | 22-26 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autism Outcome | Modified Checklist for Autism in Toddlers (M-CHAT-R) | 22-26 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurodevelopmental impairment, Disability, Umbilical cord milking, Early Cord Clamping