Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2

Completed · Not applicable

Conditions studied: Intraventricular Haemorrhage Neonatal, Death; Neonatal

In brief

This study is being done to find out whether umbilical cord milking (UCM) is at least as good as or better than delayed cord clamping (DCC) to reduce bleeding in the brain or prevent death in premature newborns. The investigators will study short and long term outcomes of infants delivered before 32 weeks gestation that receive either UCM or DCC. \* The trial was stopped by the DSMB for safety in the small strata. They subsequently allowed for continuation of the trial in infants 29-32+6 wk GA.

Key facts

Study ID

NCT03019367

Run by

Sharp HealthCare

People needed

1201

Starts

2017-06-06

Expected to finish

2022-09-16

Last updated by the study team

2022-11-23

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 23 to 32 +6 Gestational age (currently enrolling 29 to 32+6 weeks)
• Multiples without Twin-to-twin Transfusion Syndrome (TTTS)

You may not qualify if…

• Congenital anomalies
• Major cardiac defects
• Placental abruption or previa with hemorrhage
• Cord prolapse
• Hydrops
• Bleeding Accreta
• Monochorionic multiples with evidence of TTTS
• Fetal or maternal risk (i.e. compromise)
• Parents declined study
• Unlikely to return for 2 yr Follow Up

Where it is running

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

Full record on ClinicalTrials.gov

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