Neonatal Platelet Transfusion Threshold Trial
- Conditions
- ThrombocytopeniaNeonatalPlatelet TransfusionInfant, Newborn, DiseasesInfant, Extremely Low Birth WeightInfant, Small for Gestational AgeThrombosis
- Registration Number
- NCT06676904
- Lead Sponsor
- NICHD Neonatal Research Network
- 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).
- Detailed Description
Thrombocytopenia, defined as a platelet count \<150 x 10\^9/L, is a common neonatal problem that affects 22% to 35% of infants admitted to the neonatal intensive care unit. Platelets are important for primary hemostasis to prevent blood extravasation after vascular injury. Based on the role of platelets in hemostasis, prophylactic platelet transfusions are routinely administered to preterm infants with thrombocytopenia to prevent bleeding. The incidence of thrombocytopenia and administration of platelet transfusion are both inversely related to the gestational age at birth. Currently, there is uncertainty regarding the optimal platelet transfusion threshold, particularly among the most immature infants in the first week of life, which represents the period of highest bleeding risk.
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 (up to 7 postnatal days) or \<35 x 10\^9/L (8 or more postnatal days) will be randomized. 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2433
- Gestational age of 23 0/7 to 26 6/7 weeks
- Postnatal age of < 48 hours
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Survival without major or severe bleeding 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) Bleeding will be assessed using the neonatal Bleeding Assessment Tool (NeoBAT), a validated bleeding assessment tool (Venkatesh V, 2013)
- Secondary Outcome Measures
Name Time Method Death Randomization to 120 days' postnatal age, death, discharge, or transfer outside of the Study Center, whichever occurs first (an average of 112 days postnatal age) Major or severe bleeding 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) Bleeding will be assessed using the neonatal Bleeding Assessment Tool (NeoBAT), a validated bleeding assessment tool (Venkatesh V, 2013)
Number of platelet transfusions 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) At least one platelet transfusion 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) Bronchopulmonary dysplasia among survivors to 36 weeks postmenstrual age At 36 weeks postmenstrual age Retinopathy of Prematurity (ROP) Randomization to 120 days' postnatal age, death, discharge, or transfer outside of the Study Center, whichever occurs first (an average of 112 days postnatal age) Stage 3 ROP, or stage 1 or 2 in Zone 1, or plus disease
Periventricular leukomalacia Randomization to 120 days' postnatal age, death, discharge, or transfer outside of the Study Center, whichever occurs first (an average of 112 days postnatal age)
Trial Locations
- 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