Platelet Transfusion Thresholds for Low Platelet Count in Premature Infants

(NeoPlaTT Trial)

Recruiting at 19 trial locations

Overseen By Ravi M Patel, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: NICHD Neonatal Research Network

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Research Team

Ravi Patel, MD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for extremely preterm infants born between 23 and nearly 27 weeks of gestation. It's designed to help those with low platelet counts, which can lead to bleeding and other complications.

Inclusion Criteria

Gestational age of 23 0/7 to 26 6/7 weeks

I am a newborn less than 48 hours old.

Exclusion Criteria

I have not taken Vitamin K.

I am receiving comfort care or planning to withdraw care.

I have a history of bleeding or platelet disorders since birth.

Treatment Details

Interventions

• Higher Platelet Transfusion Threshold (Platelet Transfusion)
• Lower Platelet Transfusion Threshold (Platelet Transfusion)

Trial Overview The NeoPlaTT trial compares two strategies for platelet transfusions in these infants: one uses a higher threshold before transfusion, while the other uses a lower threshold. The goal is to see which approach is better for survival without major bleeding by about 40 weeks after their due date.

Participant Groups

Group I: Lower Platelet Transfusion Threshold Experimental Treatment 1 Intervention

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.

Group II: Higher Platelet Transfusion Threshold Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

NICHD Neonatal Research Network

Lead Sponsor

Trials

62

Recruited

209,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+