Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2433 participants
INTERVENTIONAL
2025-06-13
2031-04-30
Brief Summary
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Detailed Description
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The NeoPlaTT trial was designed to address this pressing uncertainty in the highest risk population (\<27 weeks GA). It will test whether a threshold of 20x10\^9/L could be safely used after the first week of life, when the risk of serious bleeding is significantly lower, and reduce the need for platelet transfusion altogether. The results of this study have a potential to change clinical practice and improve outcomes in this vulnerable population, while also decreasing costs and resource utilization.
This is a randomized trial with 1:1 allocation to parallel arms. Infants, inborn or outborn, who are admitted to participating NICUs, and who meet the inclusion and exclusion criteria, will be invited to enroll into the trial for platelet count monitoring. Only consented and enrolled infants meeting the additional platelet count trigger of \< 50 x 10\^9/L (postnatal days 1-7) or \<35 x 10\^9/L (8 or more postnatal days) will be randomized. Postnatal day 1 starts at birth. Randomization will be allowed to occur up to 36 6/7 weeks' PMA; subjects will be monitored through 40 0/7 weeks PMA. Approximately 30% of consented and enrolled infants are expected to meet the platelet count threshold for randomization.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Postnatal age of \< 48 hours
Exclusion Criteria
* Neonatal alloimmune thrombocytopenia or suspected/confirmed congenital platelet or bleeding disorder
* Receipt of platelet transfusion
* No receipt of Vitamin K
* Parents/guardian decline consent
1 Hour
48 Hours
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
NICHD Neonatal Research Network
NETWORK
Responsible Party
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Principal Investigators
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Ravi M Patel, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Waldemar A Carlo, MD
Role: primary
Valerie Chock, MD
Role: primary
Anup Katheria, MD
Role: primary
Sunah Hwang, MD
Role: primary
Ravi Patel, MD
Role: primary
Aaron Hamvas, MD
Role: primary
Tarah Colaizy, MD, MPH
Role: primary
Helen Healy, MD
Role: primary
Janell Fuller, MD
Role: primary
Carl T D'Angio, MD
Role: primary
Michael Cotten, MD
Role: primary
Stephanie Merhar, MD MS
Role: primary
Anna Maria Hibbs, MD
Role: primary
Pablo Sanchez, MD
Role: primary
Sara DeMauro, MD
Role: primary
Hendrick Weitkamp, MD
Role: primary
Myra Myckoff, MD
Role: primary
Jon Tyson
Role: primary
Kaashif Ahmad, MD
Role: primary
Robin Ohls, MD
Role: primary
References
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Venkatesh V, Curley A, Khan R, Clarke P, Watts T, Josephson C, Muthukumar P, New H, Seeney F, Morris S, Stanworth S. A novel approach to standardised recording of bleeding in a high risk neonatal population. Arch Dis Child Fetal Neonatal Ed. 2013 May;98(3):F260-3. doi: 10.1136/archdischild-2012-302443. Epub 2012 Nov 9.
Other Identifiers
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