NCT06676904 · NICHD Neonatal Research Network
Neonatal Platelet Transfusion Threshold Trial
(NeoPlaTT)
What this study is 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).
View original scientific description
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).
Interventions
PROCEDURE
Higher Platelet Transfusion Threshold
Infants randomized to this arm will be monitored for a platelet transfusion threshold of 50 x 10\^9/L during postnatal days 1-7, and then for a platelet transfusion threshold of 35 x 10\^9/L at 8 or more postnatal 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.
PROCEDURE
Lower Platelet Transfusion Threshold
Infants randomized to this arm will be monitored for a platelet transfusion threshold of 25 x 10\^9/L during postnatal days 1-7, and then for a platelet transfusion threshold of 20 x 10\^9/L at 8 or more postnatal 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.
Primary outcome measures
Survival without major or severe bleeding
Time frame: 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)
Bleeding will be assessed using the neonatal Bleeding Assessment Tool (NeoBAT), a validated bleeding assessment tool (Venkatesh V, 2013)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Birmingham, Alabama
- Palo Alto, California
- San Diego, California
- Aurora, Colorado
- Atlanta, Georgia
- Chicago, Illinois
- Iowa City, Iowa
- Boston, Massachusetts
- Albuquerque, New Mexico
- Rochester, New York
- Durham, North Carolina
- Cincinnati, Ohio
And 8 more locations — see the full list below.
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 25, 2026 · Source of record for eligibility and locations