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Neonatal Platelet Transfusion Threshold Trial
Sponsor: NICHD Neonatal Research Network
Summary
The objective of the NeoPlaTT trial is to test whether, among extremely preterm infants born at 23 0/7 to 26 6/7 weeks' gestation, a lower platelet transfusion threshold, compared to a higher threshold, improves survival without major or severe bleeding up to 40 0/7 weeks' postmenstrual age (PMA).
Key Details
Gender
All
Age Range
1 Hour - 48 Hours
Study Type
INTERVENTIONAL
Enrollment
2433
Start Date
2025-06-13
Completion Date
2031-04-30
Last Updated
2026-03-25
Healthy Volunteers
Yes
Conditions
Interventions
Higher Platelet Transfusion Threshold
Infants randomized to this arm will be monitored for a platelet transfusion threshold of 50 x 10\^9/L during postnatal days 1-7, and then for a platelet transfusion threshold of 35 x 10\^9/L at 8 or more postnatal days of life. Infants will remain on this protocol-driven threshold through 40 0/7 weeks postmenstrual age. The platelet dose will be 10 ml/kg administered over 60-120 minutes.
Lower Platelet Transfusion Threshold
Infants randomized to this arm will be monitored for a platelet transfusion threshold of 25 x 10\^9/L during postnatal days 1-7, and then for a platelet transfusion threshold of 20 x 10\^9/L at 8 or more postnatal days of life. Infants will remain on this protocol-driven threshold through 40 0/7 weeks postmenstrual age. The platelet dose will be 10 ml/kg administered over 60-120 minutes.
Locations (20)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Stanford University
Palo Alto, California, United States
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States
University of Colorado
Aurora, Colorado, United States
Emory University
Atlanta, Georgia, United States
Northwestern Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of New Mexico
Albuquerque, New Mexico, United States
University of Rochester
Rochester, New York, United States
Duke University
Durham, North Carolina, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Pediatrix Medical Group
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States