Recruiting

Platelet Transfusion Threshold

Sponsor:

NICHD Neonatal Research Network

Code:

NCT06676904

Conditions

Thrombocytopenia

Neonatal

Platelet Transfusion

Infant, Newborn, Diseases

Infant, Extremely Low Birth Weight

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

Higher Platelet Transfusion Threshold

Lower Platelet Transfusion Threshold

Study Details

Brief 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).

Conditions

Thrombocytopenia

Neonatal

Platelet Transfusion

Infant, Newborn, Diseases

Infant, Extremely Low Birth Weight

Study ID

NCT06676904

Start date

Jun 13, 2025

Status verified date

Mar, 2026

Completion date

Apr 30, 2031

Anticipated

Primary completion date

Jan 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

2433 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Primary outcome measure

  • Survival without major or severe bleeding [ Time Frame: Randomization to 40 0/7 weeks postmenstrual age, death, discharge, or transfer outside of the Study Center, whichever occurs first (an average of 98 days postnatal age) ]

Central Contacts and Locations

Central contacts

Ravi M Patel, MD

404-727-5905rmpatel@emory.edu

Abhik Das, PhD

301-230-4640adas@rti.org

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Principal Investigator:

Valerie Chock, MD

Sharp Mary Birch Hospital for Women & Newborns

Recruiting

San Diego, California, United States, 92123

Principal Investigator:

Anup Katheria, MD

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Principal Investigator:

Sunah Hwang, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30303

Principal Investigator:

Ravi Patel, MD

Northwestern Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator:

Aaron Hamvas, MD

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Tarah Colaizy, MD, MPH

319-356-3508

Principal Investigator:

Edward F. Bell, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Principal Investigator:

Helen Healy, MD

University of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87131

Principal Investigator:

Janell Fuller, MD

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Principal Investigator:

Carl T D'Angio, MD

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Cincinnati Children's Medical Center

Recruiting

Cincinnati, Ohio, United States, 45267

Principal Investigator:

Stephanie Merhar, MD MS

Case Western Reserve University, Rainbow Babies and Children's Hospital

Recruiting

Cleveland, Ohio, United States, 44106

Principal Investigator:

Anna Maria Hibbs, MD

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Principal Investigator:

Pablo Sanchez, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Sara DeMauro, MD

Vanderbilt University

Recruiting

Nashville, Tennessee, United States, 37232

Principal Investigator:

Hendrick Weitkamp, MD

University of Texas Southwestern Medical Center at Dallas

Recruiting

Dallas, Texas, United States, 75235

Principal Investigator:

Myra Wyckoff, MD

University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Jon Tyson, MD, MPH

Pediatrix Medical Group

Recruiting

San Antonio, Texas, United States, 78229

Principal Investigator:

Kaashif Ahmad, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84108

Principal Investigator:

Robin Ohls, MD

More Information

Sponsor

NICHD Neonatal Research Network

Last update posted

Mar 25, 2026

Last verified

Mar, 2026

Keywords

  • platelet transfusion
  • neonatal
  • thrombosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by NICHD Neonatal Research Network on 2026-03-25.