Neonatal Platelet Transfusion Threshold Trial

NARecruitingINTERVENTIONAL
Enrollment

2,433

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

January 31, 2031

Study Completion Date

April 30, 2031

Conditions
ThrombocytopeniaNeonatalPlatelet TransfusionInfant, Newborn, DiseasesInfant, Extremely Low Birth WeightInfant, Small for Gestational AgeThrombosis
Interventions
PROCEDURE

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.

PROCEDURE

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.

Trial Locations (20)

14642

NOT_YET_RECRUITING

University of Rochester, Rochester

19104

NOT_YET_RECRUITING

University of Pennsylvania, Philadelphia

27710

NOT_YET_RECRUITING

Duke University, Durham

30303

NOT_YET_RECRUITING

Emory University, Atlanta

35233

NOT_YET_RECRUITING

University of Alabama at Birmingham, Birmingham

37232

NOT_YET_RECRUITING

Vanderbilt University, Nashville

43205

NOT_YET_RECRUITING

Nationwide Children's Hospital, Columbus

44106

NOT_YET_RECRUITING

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

45267

RECRUITING

Cincinnati Children's Medical Center, Cincinnati

52242

NOT_YET_RECRUITING

University of Iowa, Iowa City

60611

RECRUITING

Northwestern Lurie Children's Hospital of Chicago, Chicago

75235

NOT_YET_RECRUITING

University of Texas Southwestern Medical Center at Dallas, Dallas

77030

NOT_YET_RECRUITING

University of Texas Health Science Center at Houston, Houston

78229

NOT_YET_RECRUITING

Pediatrix Medical Group, San Antonio

80045

NOT_YET_RECRUITING

University of Colorado, Aurora

84108

RECRUITING

University of Utah, Salt Lake City

87131

NOT_YET_RECRUITING

University of New Mexico, Albuquerque

92123

NOT_YET_RECRUITING

Sharp Mary Birch Hospital for Women & Newborns, San Diego

94304

NOT_YET_RECRUITING

Stanford University, Palo Alto

02215

NOT_YET_RECRUITING

Beth Israel Deaconess Medical Center, Boston

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

NICHD Neonatal Research Network

NETWORK

NCT06676904 - Neonatal Platelet Transfusion Threshold Trial | Biotech Hunter | Biotech Hunter