Neonatal Platelet Transfusion Threshold Trial

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
NICHD Neonatal Research Network
Study ID
NCT06676904
Status
Recruiting
Apply to this trial

Conditions

  • Infant, Extremely Low Birth Weight
  • Infant, Newborn, Diseases
  • Infant, Small for Gestational Age
  • Neonatal
  • Platelet Transfusion
  • Thrombocytopenia
  • Thrombosis

Eligibility Criteria

Sex
ALL
Age
1 Hour - 48 Hours
Healthy Volunteers
Accepted

Interventions

  • Higher Platelet Transfusion Threshold — PROCEDURE
    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 — PROCEDURE
    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.

Study Details

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).

Key Dates

Start date
Jun 13, 2025
Status verified
Mar 2026
Primary completion
Jan 31, 2031
Completion
Apr 30, 2031

Study Design

Enrollment
2,433 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

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

Locations (20)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Waldemar A Carlo, MD
Stanford UniversityPalo AltoCalifornia94304
Valerie Chock, MD
Valerie Chock, MD (PRINCIPAL_INVESTIGATOR)
Sharp Mary Birch Hospital for Women & NewbornsSan DiegoCalifornia92123
Anup Katheria, MD
Anup Katheria, MD (PRINCIPAL_INVESTIGATOR)
University of ColoradoAuroraColorado80045
Sunah Hwang, MD
Sunah Hwang, MD (PRINCIPAL_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30303
Ravi Patel, MD
Brenda Poindexter, MD (SUB_INVESTIGATOR)
Ravi Patel, MD (PRINCIPAL_INVESTIGATOR)
Northwestern Lurie Children's Hospital of ChicagoChicagoIllinois60611
Aaron Hamvas, MD
Aaron Hamvas, MD (PRINCIPAL_INVESTIGATOR)
University of IowaIowa CityIowa52242
Tarah Colaizy, MD, MPH
319-356-3508
Edward F. Bell, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Helen Healy, MD
Helen Healy, MD (PRINCIPAL_INVESTIGATOR)
University of New MexicoAlbuquerqueNew Mexico87131
Janell Fuller, MD
Janell Fuller, MD (PRINCIPAL_INVESTIGATOR)
University of RochesterRochesterNew York14642
Carl T D'Angio, MD
Carl T D'Angio, MD (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27710
Michael Cotten, MD
Cincinnati Children's Medical CenterCincinnatiOhio45267
Stephanie Merhar, MD MS
Vivek Narendran, MD, MBA (SUB_INVESTIGATOR)
Stephanie Merhar, MD MS (PRINCIPAL_INVESTIGATOR)
Case Western Reserve University, Rainbow Babies and Children's HospitalClevelandOhio44106
Anna Maria Hibbs, MD
Anna Maria Hibbs, MD (PRINCIPAL_INVESTIGATOR)
Nationwide Children's HospitalColumbusOhio43205
Pablo Sanchez, MD
Pablo Sanchez, MD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Sara DeMauro, MD
Sara DeMauro, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt UniversityNashvilleTennessee37232
Hendrick Weitkamp, MD
Hendrick Weitkamp, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Medical Center at DallasDallasTexas75235
Myra Myckoff, MD
Myra Wyckoff, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Health Science Center at HoustonHoustonTexas77030
Jon Tyson
Jon Tyson, MD, MPH (PRINCIPAL_INVESTIGATOR)
Pediatrix Medical GroupSan AntonioTexas78229
Kaashif Ahmad, MD
Kaashif Ahmad, MD (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84108
Robin Ohls, MD
Robin Ohls, MD (PRINCIPAL_INVESTIGATOR)

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