Neonatal Platelet Transfusion Threshold Trial
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: Newborn
Maximum Age: 2 days
Healthy Volunteers: t
View:
• Gestational age of 23 0/7 to 26 6/7 weeks
• Postnatal age of \< 48 hours
Locations
United States
Alabama
University of Alabama at Birmingham
NOT_YET_RECRUITING
Birmingham
California
Stanford University
NOT_YET_RECRUITING
Palo Alto
Sharp Mary Birch Hospital for Women & Newborns
NOT_YET_RECRUITING
San Diego
Colorado
University of Colorado
NOT_YET_RECRUITING
Aurora
Georgia
Emory University
NOT_YET_RECRUITING
Atlanta
Iowa
University of Iowa
NOT_YET_RECRUITING
Iowa City
Illinois
Northwestern Lurie Children's Hospital of Chicago
RECRUITING
Chicago
Massachusetts
Beth Israel Deaconess Medical Center
NOT_YET_RECRUITING
Boston
North Carolina
Duke University
NOT_YET_RECRUITING
Durham
New Mexico
University of New Mexico
NOT_YET_RECRUITING
Albuquerque
New York
University of Rochester
NOT_YET_RECRUITING
Rochester
Ohio
Cincinnati Children's Medical Center
RECRUITING
Cincinnati
Case Western Reserve University, Rainbow Babies and Children's Hospital
NOT_YET_RECRUITING
Cleveland
Nationwide Children's Hospital
NOT_YET_RECRUITING
Columbus
Pennsylvania
University of Pennsylvania
NOT_YET_RECRUITING
Philadelphia
Tennessee
Vanderbilt University
NOT_YET_RECRUITING
Nashville
Texas
University of Texas Southwestern Medical Center at Dallas
NOT_YET_RECRUITING
Dallas
University of Texas Health Science Center at Houston
NOT_YET_RECRUITING
Houston
Pediatrix Medical Group
NOT_YET_RECRUITING
San Antonio
Utah
University of Utah
RECRUITING
Salt Lake City
Contact Information
Primary
Ravi M Patel, MD
rmpatel@emory.edu
404-727-5905
Backup
Abhik Das, PhD
adas@rti.org
301-230-4640
Time Frame
Start Date: 2025-06-30
Estimated Completion Date: 2031-04-30
Participants
Target number of participants: 2433
Treatments
Active_comparator: 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.
Other: 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.
Related Therapeutic Areas
Sponsors
Leads: NICHD Neonatal Research Network
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)