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Clinical Trials in Mexico / NCT06676904
Recruiting Not applicable

Neonatal Platelet Transfusion Threshold Trial

NCT06676904 · tracked via the Priya Life Science Mexico tracker
Sponsor
NICHD Neonatal Research Network
Phase
Not applicable
Started
2025-06-13
Last updated
2026-03-25

Condition(s) studied

ThrombocytopeniaNeonatalPlatelet TransfusionInfant, Newborn, DiseasesInfant, Extremely Low Birth WeightInfant, Small for Gestational AgeThrombosis

Investigational drug(s) / intervention(s)

Higher Platelet Transfusion ThresholdLower Platelet Transfusion Threshold

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.

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.

Study summary

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).

Eligibility

Sex
ALL
Min age
1 Hour
Max age
48 Hours
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Survival without major or severe bleeding — 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)

Trial sites (20)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Recruiting
Stanford University Palo Alto California Recruiting
Sharp Mary Birch Hospital for Women & Newborns San Diego California Recruiting
University of Colorado Aurora Colorado Recruiting
Emory University Atlanta Georgia Recruiting
Northwestern Lurie Children's Hospital of Chicago Chicago Illinois Recruiting
University of Iowa Iowa City Iowa Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Recruiting
University of New Mexico Albuquerque New Mexico Recruiting
University of Rochester Rochester New York Recruiting
Duke University Durham North Carolina Recruiting
Cincinnati Children's Medical Center Cincinnati Ohio Recruiting
Case Western Reserve University, Rainbow Babies and Children's Hospital Cleveland Ohio Recruiting
Nationwide Children's Hospital Columbus Ohio Recruiting
University of Pennsylvania Philadelphia Pennsylvania Recruiting
Vanderbilt University Nashville Tennessee Recruiting
University of Texas Southwestern Medical Center at Dallas Dallas Texas Recruiting
University of Texas Health Science Center at Houston Houston Texas Recruiting
Pediatrix Medical Group San Antonio Texas Recruiting
University of Utah Salt Lake City Utah Recruiting

More NICHD Neonatal Research Network trials in Mexico

Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial Recruiting
Follow-up Visit of High Risk Infants Recruiting
Continued Pressure for Alveolar Protection (CPAP Trial) Recruiting
The Budesonide in Babies (BiB) Trial Active, not recruiting
Cycled Phototherapy Active, not recruiting

Other trials for the same condition

Follow-up Visit of High Risk Infants Recruiting
The Budesonide in Babies (BiB) Trial Active, not recruiting
Generic Database of Very Low Birth Weight Infants Recruiting
Management of the PDA Trial Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06676904 on ClinicalTrials.gov ↗ ← All trials in Mexico