Neonatal Platelet Transfusion Threshold Trial for Extremely Preterm Infants

This study, called NeoPlaTT, is for extremely preterm infants (born between 23 and 26 weeks of pregnancy) who are less than 48 hours old. It aims to find the best level of platelets (tiny blood cells that help stop bleeding) for these babies. Infants will be randomly assigned to one of two groups: a 'Higher Platelet Transfusion Threshold' group or a 'Lower Platelet Transfusion Threshold' group. The study will compare whether a lower platelet threshold improves a baby's survival without major or severe bleeding. The main goal is to see if babies in the lower threshold group have better outcomes up to 40 weeks postmenstrual age (which is how old the baby would be if they were still in the womb). The study is currently recruiting 2433 infants.

Study design
This is a randomized trial where infants are assigned by chance to one of two treatment groups. There will be 2433 participants in total.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed until 40 0/7 weeks postmenstrual age, death, discharge, or transfer outside of the study center, whichever happens first (an average of 98 days postnatal age).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06676904

Neonatal Platelet Transfusion Threshold Trial

Recruiting
NAAges 1–48InterventionalPrevention
NICHD Neonatal Research Network
~2,433 participants
Updated 2026-03-25 on ClinicalTrials.gov
What's tested:Higher Platelet Transfusion ThresholdLower Platelet Transfusion Threshold

At a glance

Recruiting sites
20 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Survival without major or severe bleeding
Measured over 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)
Thrombocytopenia
Neonatal
Platelet Transfusion
Infant, Newborn, Diseases
Infant, Extremely Low Birth Weight
Infant, Small for Gestational Age
Thrombosis

NCT06676904

Where you'd take part

This study runs at 20 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Iowa

    Iowa City, Iowastudy coordinator listed

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusettsno site contact published

    Recruiting

  • Case Western Reserve University, Rainbow Babies and Children's Hospital

    Cleveland, Ohiono site contact published

    Recruiting

  • Cincinnati Children's Medical Center

    Cincinnati, Ohiono site contact published

    Recruiting

  • Duke University

    Durham, North Carolinano site contact published

    Recruiting

  • Emory University

    Atlanta, Georgiano site contact published

    Recruiting

  • Nationwide Children's Hospital

    Columbus, Ohiono site contact published

    Recruiting

  • Northwestern Lurie Children's Hospital of Chicago

    Chicago, Illinoisno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Ravi M Patel, MD · PRINCIPAL_INVESTIGATOR · Emory University

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Eligibility criteria

Inclusion

Gestational age of 23 0/7 to 26 6/7 weeks
Postnatal age of \< 48 hours

Exclusion

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
  • Survival without major or severe bleedingRandomization 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)

    Bleeding will be assessed using the neonatal Bleeding Assessment Tool (NeoBAT), a validated bleeding assessment tool (Venkatesh V, 2013)