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

N

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

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).

Trial contacts and locations

0

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Central trial contact

Anup Katheria, MD; Zubair H Aghai, MD

Data sourced from clinicaltrials.gov

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