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Umbilical Cord Milking for Neonatal Asphyxia (MINVI Trial)

N/A

Waitlist Available

Led By Anup Katheria, MD

Research Sponsored by Sharp HealthCare

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-48 hours of life

Awards & highlights

MINVI Trial Summary

This trial will see if milking the umbilical cord at birth can reduce the need for newborns to go to the NICU.

Eligible Conditions

Neonatal Asphyxia

MINVI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first week of life

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first week of life

This trial's timeline: 3 weeks for screening, Varies for treatment, and first week of life for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

NICU Admission

Secondary outcome measures

Death

Hyperbilirubinemia

Placental Transfusion

+2 more

Other outcome measures

Exploratory-Blood Pressure

Exploratory-Length of Stay

Exploratory-Level of Hypoxic Ischemic Encephalopathy

+1 more

MINVI 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 the entire length of umbilical cord over two seconds, repeating three additional times as described previously. This time is not significantly different from the time for ECC as we have demonstrated in our previous trials.

Group II: Early Cord ClampingActive Control1 Intervention

This will occur by clamping the umbilical cord as soon as possible. Since both ECC and UCM will occur after a brief assessment, it is important to note that the cord clamping time will be longer than in previously conducted preterm trials (average 20 seconds) which performed the intervention on all subjects regardless of whether or not they were vigorous. In all cases, the cord clamping time will be documented to ensure consistency.

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Find a Location

Who is running the clinical trial?

University of AlbertaOTHER

886 Previous Clinical Trials

383,048 Total Patients Enrolled

3 Trials studying Neonatal Asphyxia

25 Patients Enrolled for Neonatal Asphyxia

Sharp HealthCareLead Sponsor

40 Previous Clinical Trials

15,414 Total Patients Enrolled

4 Trials studying Neonatal Asphyxia

6,918 Patients Enrolled for Neonatal Asphyxia

IWK Health CentreOTHER

125 Previous Clinical Trials

98,743 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many centers are offering this research project?

"10 different medical centres are offering this study; some of which include the University of California, Davis in Davis, Loma Linda Medical Center in Loma Linda and Sharp Grossmont Hospital in San Diego."

Answered by AI

Are new participants being welcomed for this research project?

"According to clinicaltrials.gov, the investigation is no longer searching for participants as it was last edited on February 23, 2023. The trial first appeared on May 1st 2019 and has since been superseded by 19 other ongoing studies that are actively recruiting patients right now."

Answered by AI

Does the trial encompass minors or is it restricted to adults?

"To be eligible for the trial, patients must fall between 35 weeks and 42 weeks. For those younger than 18 or older than 65, there are 14 trials available under the former age bracket and 5 in the latter."

Answered by AI

How might I qualify to participate in this clinical experiment?

"This trial is seeking 1200 patients of neonatal asphyxia with gestation periods ranging from 35 to 42 weeks. To qualify, prospective participants must be non-vigorous newborns born during this window."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Umbilical Cord Milking in Non-Vigorous Infants

Anup Katheria, M.D. 2019. "Umbilical Cord Milking in Non-Vigorous Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03631940.