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Platelet Transfusion

Platelet Transfusion Thresholds for Low Platelet Count in Premature Infants (NeoPlaTT Trial)

N/A

Waitlist Available

Led By Ravi M Patel, MD

Research Sponsored by NICHD Neonatal Research Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Postnatal age of less than 48 hours

Be younger than 18 years old

Must not have

No receipt of Vitamin K

Comfort care or withdrawal of care planned

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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)

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if giving lower amounts of platelet transfusions to very premature babies can help them survive without experiencing severe bleeding up to a certain age."

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions at the infusion site or increased risk of infections due to blood transfusions. There might also be complications from either too many or too few platelets being transferred.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a newborn less than 48 hours old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not taken Vitamin K.

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I am receiving comfort care or planning to withdraw care.

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

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I have received a platelet transfusion.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Survival without major or severe bleeding

Secondary study objectives

Major or severe bleeding

Retinopathy of Prematurity (ROP)

Other study objectives

Necrotizing enterocolitis

Thrombosis requiring therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Lower Platelet Transfusion ThresholdExperimental Treatment1 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 ThresholdActive Control1 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.

0 / 5Eligibility criteria met