Testing platelet transfusion thresholds in extremely preterm infants
Neonatal Platelet Transfusion Threshold Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2433 (estimated) |
| Ages | 1 Hour to 48 Hours |
| Sex | All |
| Sponsor | NICHD Neonatal Research Network Research network |
| Locations | 20 sites (Birmingham, Alabama and 19 other locations) |
| Trial ID | NCT06676904 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are receiving comfort care or have planned withdrawal of care will not benefit from this study.
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 performed: Other studies have explored platelet transfusion thresholds, but this specific approach in extremely preterm infants is novel and untested.
Eligibility criteria
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 this trial is running
Birmingham, Alabama and 19 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.