Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up (CORDMILK-FU)

Nemours Children's Health

Status: Enrolling

Conditions: Birth Asphyxia; Hypoxic-Ischemic Encephalopathy

Treatments: Other: Umbilical Cord Milking

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT03682042

CORDMILK FU

R01HD102967 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

An extension of the CORDMILK trial, the CORDMILK follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were non-vigorous at birth and received umbilical cord milking (UCM) or early cord clamping (ECC).

Full description

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

Enrollment: 3,442 estimated patients

Sex: All

Ages: 22 to 26 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Enrolled in CORDMILK trial
• Non-vigorous at birth

Exclusion criteria

• None

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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3,442 participants in 2 patient groups

Umbilical Cord Milking

Active Comparator group

Description:

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.

Treatment:

Other: Umbilical Cord Milking

Early Cord Clamping

No Intervention group

Description:

The umbilical cord is clamped immediately after the delivery (within 60 seconds).