RecruitingNot ApplicableNCT06676904

Neonatal Platelet Transfusion Threshold Trial


Sponsor

NICHD Neonatal Research Network

Enrollment

2,433 participants

Start Date

Jun 13, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 1 HourMax Age: 48 Hours

Inclusion Criteria2

  • Gestational age of 23 0/7 to 26 6/7 weeks
  • Postnatal age of \< 48 hours

Exclusion Criteria5

  • Comfort care or withdrawal of care planned
  • Neonatal alloimmune thrombocytopenia or suspected/confirmed congenital platelet or bleeding disorder
  • Receipt of platelet transfusion
  • No receipt of Vitamin K
  • Parents/guardian decline consent

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Interventions

PROCEDUREHigher 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.

PROCEDURELower 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

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NCT06676904


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