Neonatal Platelet Transfusion Threshold Trial
NICHD Neonatal Research Network
2,433 participants
Jun 13, 2025
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
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
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.
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)
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NCT06676904