2433 Participants Needed

Platelet Transfusion Thresholds for Low Platelet Count in Premature Infants

(NeoPlaTT Trial)

Recruiting at 19 trial locations
AD
RM
Overseen ByRavi M Patel, MD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: NICHD Neonatal Research Network
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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).

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

Is platelet transfusion safe for premature infants with low platelet counts?

Recent studies suggest that using a lower threshold for platelet transfusions in premature infants may be safer, as higher thresholds have been linked to increased risks of death and bleeding. However, there is still a need for more research to fully understand the safety and best practices for platelet transfusions in these infants.12345

How does the treatment of different platelet transfusion thresholds for low platelet count in premature infants differ from other treatments?

This treatment is unique because it explores different thresholds for platelet transfusions in premature infants, specifically comparing higher and lower platelet count thresholds. Recent studies suggest that a lower threshold (25 x 10^9/L) may be safer and more effective, as higher thresholds could increase the risk of harm, including death and bleeding, due to potential disruptions in the infant's delicate blood balance.12567

What data supports the effectiveness of the treatment for platelet transfusion thresholds in premature infants?

Research shows that using a lower platelet transfusion threshold of 25 x 10^9/L in premature infants can reduce the risk of major bleeding and death compared to a higher threshold of 50 x 10^9/L. This approach has been associated with a 7% reduction in absolute risk of these adverse outcomes.178910

Who Is on the Research Team?

Dr. Ravi M Patel, MD | Atlanta, GA ...

Ravi Patel, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Randomization and Monitoring

Infants are randomized to either a higher or lower platelet transfusion threshold and monitored for platelet counts

Up to 36 6/7 weeks postmenstrual age
Continuous monitoring in NICU

Follow-up

Participants are monitored for survival without major or severe bleeding and other outcomes

Up to 40 0/7 weeks postmenstrual age

What Are the Treatments Tested in This Trial?

Interventions

  • Higher Platelet Transfusion Threshold
  • Lower Platelet Transfusion Threshold
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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Lower Platelet Transfusion ThresholdExperimental Treatment1 Intervention
Group II: Higher Platelet Transfusion ThresholdActive Control1 Intervention

Find a Clinic Near You

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+

Citations

Benefits of lower neonatal platelet transfusion thresholds. [2021]
Platelet transfusion for neonates with thrombocytopaenia: protocol for a systematic review. [2021]
Platelet transfusion thresholds in premature neonates (PlaNeT-2 trial). [2019]
Platelets in the neonatal period: developmental differences in platelet production, function, and hemostasis and the potential impact of therapies. [2016]
Preterm neonates benefit from low prophylactic platelet transfusion threshold despite varying risk of bleeding or death. [2021]
Platelet transfusion thresholds in neonatal medicine. [2020]
Prophylactic platelet transfusion in children with thrombocytopenic disorders: a retrospective review. [2019]
Platelet transfusion in the management of severe thrombocytopenia in neonatal intensive care unit patients. [2019]
Thrombocytopenia, bleeding, and use of platelet transfusions in sick neonates. [2022]
Are thrombocytopenia and platelet transfusions associated with major bleeding in preterm neonates? A systematic review. [2020]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity