Neonatal Platelet Transfusion Threshold Trial (NeoPlaTT)

NICHD Neonatal Research Network

Status: Not yet enrolling

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

Treatments: Procedure: Higher Platelet Transfusion Threshold; Procedure: Lower Platelet Transfusion Threshold

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT06676904

1U24HL173304-01 (U.S. NIH Grant/Contract)

UG3HL173303 (U.S. NIH Grant/Contract)

NICHD-NRN-0065

Details and patient eligibility

About

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).

Full 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.

Enrollment: 2,433 estimated patients

Sex: All

Ages: 1 to 48 hours old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,433 participants in 2 patient groups

Higher Platelet Transfusion Threshold

Active Comparator group

Description:

Infants randomized to this arm will be monitored for a platelet transfusion threshold of 50 x 10\^9/L up to 7 days of life, and then for a platelet transfusion threshold of 35 x 10\^9/L at 7 or more 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.

Treatment:

Procedure: Higher Platelet Transfusion Threshold

Lower Platelet Transfusion Threshold

Other group

Description:

Infants randomized to this arm will be monitored for a platelet transfusion threshold of 25 x 10\^9/L up to 7 days of life, and then for a platelet transfusion threshold of 20 x 10\^9/L at 7 or more 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.

Treatment:

Procedure: Lower Platelet Transfusion Threshold