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

Status unconfirmed · Not applicable

Conditions studied: Neurodevelopmental Abnormality

In brief

An extension of the PREMOD2 trial, the PREMOD2 Follow-Up trial will evaluate the neurodevelopmental outcomes at 22-26 months corrected age of preterm children who received UCM or DCC. This prospective multi-national randomized controlled trial (RCT) is a two-arm parallel non-inferiority design of two alternative approaches of treatment.

Key facts

Study ID

NCT03476980

Run by

Sharp HealthCare

People needed

1200

Starts

2019-07-06

Expected to finish

2024-12-01

Last updated by the study team

2022-11-25

Who can join

Age: 2 and older, up to 4. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Children enrolled in the PREMOD2 non-inferiority trial at birth who did not survive or are lost to follow-up.

Where it is running

• University of Alabama — Birmingham, Alabama, United States (enrolling)
• Loma Linda Medical Center — Loma Linda, California, United States (enrolling)
• LAC+USC Medical Center — Los Angeles, California, United States (enrolling)
• PIH Health Good Samaritan Hospital — Los Angeles, California, United States (enrolling)
• University of California, Irvine Medical Center — Orange, California, United States (enrolling)
• Sharp Grossmont Hospital — San Diego, California, United States (enrolling)
• Sharp Mary Birch Hospital for Women and Newborns — San Diego, California, United States (enrolling)
• Christiana Care — Newark, Delaware, United States (enrolling)
• John H. Stroger, Jr. Hospital of Cook County — Chicago, Illinois, United States (enrolling)
• University of Mississippi Medical Center — Jackson, Mississippi, United States (enrolling)
• St. Louis University — St Louis, Missouri, United States (enrolling)
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States (enrolling)
• Providence St. Vincent Medical Center — Portland, Oregon, United States (enrolling)
• Magee-Womens Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)
• Governors of University of Alberta — Edmonton, Alberta, Canada (enrolling)
• University of ULM — Ulm, Baden-Wurttemberg, Germany (enrolling)
• Cork University Maternity Hospital — Cork, Ireland (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.