Umbilical Cord Milking in Neonates Who Are Depressed at Birth-Developmental Follow Up (MIDAB-FU)

Study Overview
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Brief Summary
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An extension of the MIDAB trial, the MIDAB-Follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were depressed at birth and received umbilical cord milking (UCM) or immediate cord clamping (ICC).

Detailed Description
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The MIDAB-Follow-up trial will examine the difference in survival and neurodevelopmental impairment of infants who were depressed at birth and enrolled in MIDAB trial. The difference in survival and neurodevelopmental impairment in infants who received UCM and ICC will be assessed using standardized neurological and developmental assessment tools at 22-26 months of age.

Official Title
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Long-term Outcomes of Umbilical Cord Milking in Term and Late Preterm Neonates Who Are Depressed at Birth

Conditions
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Hypoxic-Ischemic Encephalopathy, Birth Asphyxia

Intervention / Treatment
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* Other: Umbilical Cord Milking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled in MIDAB trial Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 3 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Neurodevelopmental assessments will be done at 2 years of age (22-26 months) for subjects who were randomized to receive either immediate cord clamping or umbilical cord milking as part of the MIDAB 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 10-15 seconds. | Other: 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 10-15 seconds.<br>|
| No Intervention: Immediate Cord Clamping<br>The umbilical cord is clamped immediately after the delivery. | |

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 |
| --- | --- | --- |
| Fidgety Movements at 3 months of age | Assessment of Fidgety Movements by Prechtl's method | 3-5 months | 
| Neurodevelopmental Outcome at 1 Year of Age | Developmental Activities Screening Inventory - Second Edition (DASI-II) | 10-14 months | 
| Autism Outcome | Modified Checklist for Autism in Toddlers (M-CHAT-R) | 22-26 months |