Testing platelet transfusion thresholds in extremely preterm infants
Official title: Neonatal Platelet Transfusion Threshold Trial
Run by NICHD Neonatal Research Network · NCT06676904 · Data updated 2026-11-12
This study is testing if giving platelet transfusions at a lower level can help extremely premature babies survive without major bleeding during their first week of life.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Hour to 48 Hours |
| Sex | All |
| Enrollment | 2433 (estimated) |
| Sponsor | NICHD Neonatal Research Network Research network |
| Locations | 20 sites (Birmingham, Alabama and 19 other locations) |
| Status | Recruiting |
| Started | June 13, 2025 |
| Main results expected | January 31, 2031 |
| Study ends | April 30, 2031 |
| Registry record updated | March 25, 2026 |
| Trial ID | NCT06676904 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are extremely preterm infants born at 23 0/7 to 26 6/7 weeks' gestation who are less than 48 hours old.
✕Probably not a fit
Patients who are receiving comfort care or have planned withdrawal of care will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The NeoPlaTT trial aims to determine if a lower platelet transfusion threshold of 20x10^9/L can improve survival without major bleeding in extremely preterm infants born between 23 0/7 to 26 6/7 weeks' gestation. This randomized trial will compare outcomes between infants receiving transfusions at this lower threshold versus a higher threshold. The study focuses on the first week of life, a critical period for these vulnerable infants, to assess the safety and efficacy of the proposed threshold. By addressing the uncertainty surrounding optimal transfusion practices, the trial seeks to enhance clinical outcomes and reduce healthcare costs.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and reduced bleeding complications in extremely preterm infants.
How similar studies have gone: Other studies have explored platelet transfusion thresholds, but this specific approach in extremely preterm infants is novel and untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 it's running
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University of Alabama at Birmingham
Birmingham, Alabama, United States Recruiting -
Stanford University
Palo Alto, California, United States Recruiting -
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States Recruiting -
University of Colorado
Aurora, Colorado, United States Recruiting -
Emory University
Atlanta, Georgia, United States Recruiting -
Northwestern Lurie Children's Hospital of Chicago
Chicago, Illinois, United States Recruiting
Show 14 more locations
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University of Iowa
Iowa City, Iowa, United States Recruiting -
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States Recruiting -
University of New Mexico
Albuquerque, New Mexico, United States Recruiting -
University of Rochester
Rochester, New York, United States Recruiting -
Duke University
Durham, North Carolina, United States Recruiting -
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States Recruiting -
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States Recruiting -
Nationwide Children's Hospital
Columbus, Ohio, United States Recruiting -
University of Pennsylvania
Philadelphia, Pennsylvania, United States Recruiting -
Vanderbilt University
Nashville, Tennessee, United States Recruiting -
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States Recruiting -
University of Texas Health Science Center at Houston
Houston, Texas, United States Recruiting -
Pediatrix Medical Group
San Antonio, Texas, United States Recruiting -
University of Utah
Salt Lake City, Utah, United States Recruiting
Study contacts
- Principal investigator: Ravi M Patel, MD — Emory University
- Study coordinator: Ravi M Patel, MD
- Email: rmpatel@emory.edu
- Phone: 404-727-5905
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Other studies for the same condition or treatment. Recruiting studies are listed first.
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Personalized blood-thinner plan for leg artery disease after repair
A personalized plan using a blood test to tailor antiplatelet therapy is being tested against standard treatment in adults with PAD after a procedure to restore blood flow.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.