Your session is about to expire
← Back to Search
Cord Milking vs Delayed Clamping for Premature Birth (PREMOD2 Trial)
N/A
Waitlist Available
Led By Anup C 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 2st 24 hours of life
Awards & highlights
PREMOD2 Trial Summary
This trial will compare the early hemodynamic effects of delayed cord clamping to umbilical cord milking.
Who is the study for?
This trial is for premature newborns between 23 weeks and nearly 28 weeks old who are already enrolled in the PREMOD2 trial. It's not open to those where Near Infrared Spectroscopy (NIRS) devices or research personnel aren't available.Check my eligibility
What is being tested?
The study compares two methods of helping babies just born prematurely: Umbilical Cord Milking (UCM) and Delayed Cord Clamping (DCC). It measures early effects on heart rate, brain oxygen, blood pressure, and other vital signs from birth up to one day old.See study design
What are the potential side effects?
Since this study observes natural procedures rather than drugs, traditional side effects are not applicable. However, there may be differences in physiological responses like blood pressure or oxygen levels between the two methods.
PREMOD2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2st 24 hours of life
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2st 24 hours of life
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
StO2 - 10M
Secondary outcome measures
Blood Pressure NICU
HR - 10M
HR 24H
+1 morePREMOD2 Trial Design
2Treatment groups
Active Control
Group I: Umbilical Cord MilkingActive Control1 Intervention
Milking the umbilical cord 4 times towards the infant at a speed of 20cm over 2 seconds.
Group II: Delayed Cord ClampingActive Control1 Intervention
Delayed clamping of the umbilical cord for at least 60 seconds.
Find a Location
Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,674,609 Total Patients Enrolled
65 Trials studying Premature Birth
119,389 Patients Enrolled for Premature Birth
Sharp HealthCareLead Sponsor
40 Previous Clinical Trials
17,023 Total Patients Enrolled
5 Trials studying Premature Birth
3,013 Patients Enrolled for Premature Birth
University of UlmOTHER
182 Previous Clinical Trials
66,694 Total Patients Enrolled
2 Trials studying Premature Birth
1,218 Patients Enrolled for Premature Birth
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The device used for near-infrared spectroscopy (NIRS) is not available for this study.Research staff are not available for my participation.Participants must be between 23 weeks and 27 weeks and 6 days of age.
Research Study Groups:
This trial has the following groups:- Group 1: Umbilical Cord Milking
- Group 2: Delayed Cord Clamping
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any criteria outlining who is eligible to participate in this trial?
"This trial is currently accepting 121 participants who suffer from anoxia and have a brain age between 23 weeks and 28 weeks."
Answered by AI
Are there any vacancies for potential participants in this research project?
"At present, this medical trial is not recruiting. Although the first posting was on June 6th of 2017 and it has been edited as recently as December 9th 2021, no participants are currently being sought out. Nevertheless, 424 other clinical trials are still actively enrolling patients."
Answered by AI
Does this trial include those aged 75 and over?
"This clinical trial requires potential patients to be aged 23 Weeks to 28 Weeks. There are 220 trials for those younger than 18 years old and 181 available for those older than 65 years of age."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger