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Umbilical Cord Milking for Hypoxic-Ischemic Encephalopathy (CORDMILK Trial)

N/A
Recruiting
Led By Zubair H Aghai
Research Sponsored by Nemours Children's Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Non-vigorous neonates born between 35-42 weeks
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 days to 2 weeks
Awards & highlights

Summary

The investigators will conduct a study on non-vigorous infants at birth to determine if umbilical cord milking (UCM) results in lower rate of moderate to severe hypoxic ischemic encephalopathy (HIE) or death than early clamping and for infants who are non-vigorous at birth and need immediate resuscitation.

Eligible Conditions
  • Hypoxic-Ischemic Encephalopathy
  • Neonatal Asphyxia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 days to 2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 days to 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hypoxic-Ischemic Encephalopathy
Secondary outcome measures
MRI of the brain

Trial Design

2Treatment groups
Active Control
Group I: Umbilical Cord MilkingActive Control1 Intervention
The delivering practitioner will place the newborn below the level of the incision (at the edge of the table) at C/S and a second team member will milk the cord four times. For vaginal delivery, the delivering obstetrician, midwife or perinatal provider will hold the infant against their body or place the infant on the mother's abdomen and the cord will be milked either four times by the obstetrical provider or by a second team member. For the cord milking procedure, the obstetrical provider will milk 20-30 centimeters length of the umbilical cord over two seconds, repeating three additional times as described previously. This time is not significantly different from the time for ECC.
Group II: Early Cord ClampingActive Control1 Intervention
Umbilical cord will be clamped immediately after birth (within 60 seconds)

Find a Location

Who is running the clinical trial?

University of San DiegoOTHER
4 Previous Clinical Trials
7,497 Total Patients Enrolled
St. Louis UniversityOTHER
194 Previous Clinical Trials
38,481 Total Patients Enrolled
Mahatma Gandhi Institue of Medical Sciences, Wardha, IndiaUNKNOWN
~888 spots leftby Jun 2025
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