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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-17

Study Completion Date

2026-08-16

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).

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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.

Conditions

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Hypoxic-Ischemic Encephalopathy Birth Asphyxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Neurodevelopmental providers will be blinded to the randomization of the toddler during the examination.

Study Groups

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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 10-15 seconds.

Group Type ACTIVE_COMPARATOR

Umbilical Cord Milking

Intervention Type OTHER

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.

Immediate Cord Clamping

The umbilical cord is clamped immediately after the delivery.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 10-15 seconds.

Intervention Type OTHER