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Cord Clamping Techniques for Neonatal Asphyxia

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 +/- 6 hours of life
Awards & highlights

Study Summary

This trial collects data from infants who aren't active; parents can consent for an optional echocardiogram.

Eligible Conditions
  • Neonatal Asphyxia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 +/- 6 hours of life
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 +/- 6 hours 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
Cardiac Output
Secondary outcome measures
Peak Systolic Strain and Strain rate
Peak Systolic Tissue Doppler
Right Ventricular Output
+1 more

Trial Design

2Treatment groups
Active Control
Group I: 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.
Group II: 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.

Find a Location

Who is running the clinical trial?

Sharp HealthCareLead Sponsor
40 Previous Clinical Trials
17,110 Total Patients Enrolled
4 Trials studying Neonatal Asphyxia
8,614 Patients Enrolled for Neonatal Asphyxia
Sharp Mary Birch Hospital for Women & NewbornsOTHER
12 Previous Clinical Trials
6,508 Total Patients Enrolled
1 Trials studying Neonatal Asphyxia
1,730 Patients Enrolled for Neonatal Asphyxia
Anup Katheria, MD3.02 ReviewsPrincipal Investigator - Sharp Mary Birch Hospital for Women & Newborns
Sharp HealthCare
15 Previous Clinical Trials
13,016 Total Patients Enrolled
3 Trials studying Neonatal Asphyxia
8,614 Patients Enrolled for Neonatal Asphyxia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
MINVI Echocardiography Sub-Study
Anup Katheria, M.D. 2019. "MINVI Echocardiography Sub-Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03798093.
~5 spots leftby Apr 2025
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