Clinical trial Recruiting at 20 sites Interventional Ages 1 Hour to 48 Hours

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 typeInterventional
Ages1 Hour to 48 Hours
SexAll
Enrollment2433 (estimated)
SponsorNICHD Neonatal Research Network
Research network
Locations20 sites (Birmingham, Alabama and 19 other locations)
StatusRecruiting
StartedJune 13, 2025
Main results expectedJanuary 31, 2031
Study endsApril 30, 2031
Registry record updatedMarch 25, 2026
Trial IDNCT06676904 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.