Treatment for Hemorrhage

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
St. Louis University, Saint Louis, MO
Hemorrhage+3 More
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2

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Eligible Conditions

  • Hemorrhage
  • Intraventricular Haemorrhage Neonatal
  • Neonatal Mortality

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 6 secondary outcomes in patients with Hemorrhage. Measurement will happen over the course of In the first 10 minutes of life.

Hour 2
Hemoglobin/Hematocrit at 4 hours
In the first 10 minutes of life
Delivery room interventions
Hour 24
Blood pressures in the first 24 hours of life
Month 6
Incidence of severe IVH or death
Month 6
All Grade IVH
Incidence of Severe IVH or death in infants <28 weeks gestation
Severe IVH (Grade 3 or 4)

Trial Safety

Trial Design

2 Treatment Groups

Delayed cord clamping DCC
1 of 2
Umbilical cord milking UCM
1 of 2
Active Control

This trial requires 1200 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Delayed cord clamping DCC
Procedure
Delayed clamping of the umbilical cord for at least 60 seconds.
Umbilical cord milking UCM
Procedure
Milking the umbilical cord 4 times towards the infant at a speed of 20cm/2seconds.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion at discharge, up to 6 months corrected gestational age (cga)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion at discharge, up to 6 months corrected gestational age (cga) for reporting.

Who is running the study

Principal Investigator
A. K. M.
Anup Katheria M.D., Director of Neonatal Research Institute
Sharp HealthCare

Closest Location

St. Louis University - Saint Louis, MO

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Multiples without TTTS are those without the complication of twin-to-twin transfusion syndrome show original
The clinic is accepting patients who are 29 to 32+6 weeks pregnant. show original

Patient Q&A Section

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Other questions from users

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

Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Hemorrhage by sharing your contact details with the study coordinator.