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
RECRUITING
Birmingham
California
Stanford University
RECRUITING
Palo Alto
Sharp Mary Birch Hospital for Women & Newborns
RECRUITING
San Diego
Colorado
University of Colorado
RECRUITING
Aurora
Georgia
Emory University
RECRUITING
Atlanta
Iowa
University of Iowa
RECRUITING
Iowa City
Illinois
Northwestern Lurie Children's Hospital of Chicago
RECRUITING
Chicago
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
North Carolina
Duke University
RECRUITING
Durham
New Mexico
University of New Mexico
RECRUITING
Albuquerque
New York
University of Rochester
RECRUITING
Rochester
Ohio
Cincinnati Children's Medical Center
RECRUITING
Cincinnati
Case Western Reserve University, Rainbow Babies and Children's Hospital
RECRUITING
Cleveland
Nationwide Children's Hospital
RECRUITING
Columbus
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Tennessee
Vanderbilt University
RECRUITING
Nashville
Texas
University of Texas Southwestern Medical Center at Dallas
RECRUITING
Dallas
University of Texas Health Science Center at Houston
RECRUITING
Houston
Pediatrix Medical Group
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: 2025-06-13
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)