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Delayed Cord Clamping vs. Umbilical Cord Milking for Premature Birth (PREMOD2FU Trial)

N/A

Recruiting

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

Children enrolled in the PREMOD2 non-inferiority trial at birth who survive to 2 years corrected age.

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 22-26 months corrected gestational age (cga). all assessments may be extended to 42 months cga due to covid-19 pandemic.

Awards & highlights

PREMOD2FU Trial Summary

This trial will compare two methods of treatment for preterm children and evaluate the neurodevelopmental outcomes at 22-26 months corrected age.

Who is the study for?

This trial is for children born prematurely who were part of the PREMOD2 study and survived to two years corrected age. It's not open to those who did not survive or cannot be followed up.Check my eligibility

What is being tested?

The trial compares neurodevelopmental outcomes at around two years old in preterm infants who had either delayed cord clamping (DCC) or umbilical cord milking (UCM) at birth.See study design

What are the potential side effects?

Since this follow-up study focuses on long-term development rather than immediate side effects, it does not directly address new side effects but monitors developmental progress post-interventions.

PREMOD2FU Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My child was in the PREMOD2 trial at birth and is now 2 years old.

PREMOD2FU Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 22-26 months corrected gestational age (cga). all assessments may be extended to 42 months cga due to covid-19 pandemic.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~22-26 months corrected gestational age (cga). all assessments may be extended to 42 months cga due to covid-19 pandemic.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 22-26 months corrected gestational age (cga). all assessments may be extended to 42 months cga due to covid-19 pandemic. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Developmental Outcome

Secondary outcome measures

Any grade intraventricular hemorrhage (IVH) in premature newborns 23 - 32+6 weeks GA who received UCM or DCC by mode of delivery (C-Section vs vaginal delivery)

Cerebral Palsy (CP)

Compare levels of developmental impairment as assessed by BSID-3 or 4 versus the ASQ-3 screening tool.

+8 more

Other outcome measures

Exploratory, hypothesis-generating

PREMOD2FU Trial Design

2Treatment groups

Active Control

Group I: Randomized to Umbilical Cord Milking at birthActive Control1 Intervention

Milking the umbilical cord towards the infant at a speed of 20cm/2seconds at birth.

Group II: Randomized to Delayed Cord Clamping at birthActive Control1 Intervention

Delayed clamping of the umbilical cord at birth.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Providence HospitalOTHER

4 Previous Clinical Trials

2,995 Total Patients Enrolled

University of UlmOTHER

182 Previous Clinical Trials

65,615 Total Patients Enrolled

Thrasher Research FundOTHER

132 Previous Clinical Trials

93,224 Total Patients Enrolled

Media Library

Randomized to Delayed Cord Clamping at birth Clinical Trial Eligibility Overview. Trial Name: NCT03476980 — N/A

Neurodevelopmental Disorder Research Study Groups: Randomized to Umbilical Cord Milking at birth, Randomized to Delayed Cord Clamping at birth

Neurodevelopmental Disorder Clinical Trial 2023: Randomized to Delayed Cord Clamping at birth Highlights & Side Effects. Trial Name: NCT03476980 — N/A

Randomized to Delayed Cord Clamping at birth 2023 Treatment Timeline for Medical Study. Trial Name: NCT03476980 — N/A

Frequently Asked Questions

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

In how many distinct locations is this experiment currently being conducted?

"This clinical trial is being conducted in multiple locations throughout the United States. Examples of participating medical centres are University of Utah, located in Salt Lake City; University of California Irvine Medical Center based out of Orange and LAC+USC Medical Centre situated in Los Angeles. There are a total 16 sites offering this study."

Answered by AI

Am I eligible to contribute to this medical experiment?

"This scientific research is in search of 1200 individuals between the ages of 22 Months and 42 Months that suffer from a neurodevelopmental abnormality. In addition to these conditions, participants must have been enrolled into PREMOD2 pre-birth and survived until they reach 2 years post-corrective age."

Answered by AI

How many individuals are being enrolled in this clinical investigation?

"This clinical trial requires 1200 qualified patients to take part in it. These candidates can be recruited from 2 diverse locations: University of Utah, Salt Lake City and the University of California, Irvine Medical Center in Orange."

Answered by AI

Does this research include the elderly population over 80 years of age?

"This trial is exclusively open to those aged between 22 and 42 months. Further research opportunities exist for children younger than 18 years old (231 studies) as well adults over the age of 65 (151 studies)."

Answered by AI

Is the enrollment window still open for this experiment?

"Affirmative. Clinicaltrials.gov data shows that this trial is currently recruiting, with the original posting being made on July 6th 2019 and most recent update taking place on November 22nd 202022. 1200 participants need to be recruited from 16 separate sites."

Answered by AI

Recent research and studies

The Journal of PediatricsJournal

A Randomized Clinical Trial of Umbilical Cord Milking Vs Delayed Cord Clamping in Preterm Infants: Neurodevelopmental Outcomes at 22-26 Months of Corrected Age

Katheria, Anup, Donna Garey, Giang Truong, Natacha Akshoomoff, Jane Steen, Mauricio Maldonado, Debra Poeltler, Mary Jane Harbert, Yvonne E. Vaucher, and Neil Finer. 2018. “A Randomized Clinical Trial of Umbilical Cord Milking Vs Delayed Cord Clamping in Preterm Infants: Neurodevelopmental Outcomes at 22-26 Months of Corrected Age”. The Journal of Pediatrics. Elsevier BV. doi:10.1016/j.jpeds.2017.10.037.

PediatricsJournal

Umbilical Cord Milking Versus Delayed Cord Clamping in Preterm Infants

Katheria, Anup C., Giang Truong, Larry Cousins, Bryan Oshiro, and Neil N. Finer. 2015. “Umbilical Cord Milking Versus Delayed Cord Clamping in Preterm Infants”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2015-0368.

clinicaltrials.govStudy

Two Year Developmental Follow-up for PREMOD2 Trial (Premature Infants Receiving Milking or Delayed Cord Clamping)

2019. "Two Year Developmental Follow-up for PREMOD2 Trial (Premature Infants Receiving Milking or Delayed Cord Clamping)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03476980.

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