Transfusions of Prematures (TOP) Trial: Does a Liberal Red Blood Cell Transfusion Strategy Improve Neurologically-Intact Survival of Extremely-Low-Birth-Weight Infants as Compared to a Restrictive Strategy?

Study ID
STU 102012-043

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Children's Medical Center-Dallas
  • Parkland Health & Hospital System

Contact
Diana Vasil
214-648-3789
diana.vasil@utsouthwestern.edu

Principal Investigator
Myra Wyckoff

Summary

Long-term outcomes of extremely low birth weight (eLBW) preterm infants, those weighing less than or equal to 1000 grams at birth, are poor and pose a major health care burden. almost all of these infants are transfused, but at differing hemoglobin thresholds. This results in conflicting data on when they should be transfused and prevents an evidence-based recommendation. The PinT study or Prematures in need of Transfusion(Kirpanlani, H, 2006) suggested that higher hemoglobin thresholds for transfusion may be beneficial to long term neurocognitive outcomes at 18-22 months (Whyte, R. 2009).The potential impact is high if this trial verifies this. The study will randomize infants less than or equal to 1000 grams birth weight and less than 29 weeks gestational age to receive red blood cell transfusions according to one of two strategies of hemoglobin thresholds, either a high hemoglobin (liberal transfusions) or a low hemoglobin (restrictive transfusions) algorithm. ToP is powered to demonstrate which strategy reduces the primary outcome of death or neurodisability in survivors at 22 -26 months corrected age.

Participant Eligibility

-birth weight less than or equal to 1000 grams
-gestational age between 22 0/7 weeks to 28 6/7 weeks
-admission to an NRN center within 48 hours of birth
-ability to randomize within 48 hours