Summary

Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Uday Devaskar (ucla)

Description

Summary

The objective of the TOP trial is to determine whether higher hemoglobin thresholds for transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the primary outcome of survival and rates of neurodevelopmental impairment (NDI) at 22-26 months of age, using standardized assessments by Bayley.

Official Title

Transfusion 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?

Details

Long-term outcomes of extremely low birth weight (ELBW) preterm infants, those weighing less than or equal to 1000 g at birth, are poor and pose a major health care burden. Virtually all of these infants are transfused, but at inconsistent hemoglobin (Hgb) thresholds. The investigators propose in TOP to randomize infants less than or equal to 1000 g BW and gestational age at least 22 weeks but less than 29 weeks to receive red blood cell (RBC) transfusions according to one of two strategies of Hgb thresholds, either a high Hgb (liberal transfusion) or a low Hgb (restrictive transfusion) algorithm. It is currently unknown which transfusion strategy is superior. TOP is powered to demonstrate which strategy reduces the primary outcome of death or neurodisability in survivors at 22-26 months. A secondary study entitled "Effect of Blood Transfusion Practices on Cerebral and Somatic Oximetry", also known as the NIRS study, will determine differences in cerebral oxygenation and fractional tissue oxygen extraction with NIRS between high and low hemoglobin threshold groups during red blood cell transfusions. The investigators also propose to determine whether abnormal cerebral NIRS measures are a better predictor of NDI than hemoglobin alone and whether abnormal mesenteric NIRS measures are associated with the development of NEC within the 48 hours following a transfusion. A secondary study entitled "Economic Evaluation Ancillary to the Transfusion of Prematures Randomized Controlled Trial" will determine whether higher transfusion threshold will result in lower total costs to society over the first 22 to 26 corrected months of life and estimate the incremental cost-effectiveness ratio for survival without neurodevelopmental impairment, from the perspective of society, the third-party payer, and the family. Extended follow-up: Subjects will be seen for a follow-up visit at 5-6 years corrected age to assess neurological and functional outcomes at early school age based on neonatal transfusion threshold.

Keywords

Infant, Newborn, Diseases Infant, Extremely Low Birth Weight Infant, Small for Gestational Age Bronchopulmonary Dysplasia (BPD) Anemia NICHD Neonatal Research Network Very Low Birth Weight (VLBW) Extremely Low Birth Weight (ELBW) Transfusions Bronchopulmonary Dysplasia Birth Weight Liberal Cell Transfusion Restricted red cell transfusion Low Threshold Transfusion High Threshold Transfusion

Eligibility

You can join if…

  • Birth weight less than or equal to 1000 grams.
  • Gestational age at least 22 weeks but less than 29 weeks
  • Admitted to the NICU within 48 hours of life

You CAN'T join if...

  • Considered nonviable by the attending neonatologist
  • Cyanotic congenital heart disease
  • Parents opposed to the transfusion of blood
  • Parents with hemoglobinopathy or congenital anemia
  • In-utero fetal transfusion
  • Twin-to-twin transfusion syndrome
  • Isoimmune hemolytic disease
  • Lack of parental consent
  • Severe acute hemorrhage, acute shock, sepsis with coagulopathy, or need for perioperative transfusion.
  • Prior blood transfusion on clinical grounds beyond the first 6 hours of life
  • Infant has received erythropoietin prior to randomization, or is intended to receive erythropoietin through the neonatal course
  • Congenital condition, other than premature birth, that adversely affects life expectancy or neurodevelopment.
  • High probability that the family is socially disorganized to the point of being unable to attend follow-up at 22-26 months.

Locations

  • University of California - Los Angeles
    Los Angeles California 90025 United States
  • Stanford University
    Palo Alto California 94304 United States

Lead Scientist at University of California Health

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
NICHD Neonatal Research Network
ID
NCT01702805
Phase
Phase 3
Study Type
Interventional
Last Updated