Transfusion of Prematures Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anemia
- Bronchopulmonary Dysplasia (BPD)
- Infant, Extremely Low Birth Weight
- Infant, Newborn Diseases
- Infant, Small for Gestational Age
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 48 years
- Gender
- Both males and females
Description
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 TO...
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.
Tracking Information
- NCT #
- NCT01702805
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Investigators
- Principal Investigator: Michele C Walsh, MD Case Western Reserve University, Rainbow Babies and Children's Hospital Principal Investigator: Abhik Das, PhD RTI International Principal Investigator: Beena Sood, MD Wayne State University Principal Investigator: Abbot R Laptook, MD Brown University, Women & Infants Hospital of Rhode Island Principal Investigator: Michael Cotten, MD Duke University Principal Investigator: Ravi Patel, MD Emory University Principal Investigator: Greg Sokol, MD Indiana University Principal Investigator: Krisa P Van Meurs, MD Stanford University Principal Investigator: Brenda Poindexter, MD Children's Hospital Medical Center, Cincinnati Principal Investigator: Waldemar A Carlo, MD University of Alabama at Birmingham Principal Investigator: Kristi L Watterberg, MD University of New Mexico Principal Investigator: Myra Wyckoff, MD University of Texas, Southwestern Medical Center at Dallas Principal Investigator: Kathleen A Kennedy, MD, MPH The University of Texas Health Science Center, Houston Principal Investigator: Carl T D'Angio, MD University of Rochester Principal Investigator: Pablo Sanchez, MD Research Institute at Nationwide Children's Hospital Principal Investigator: William Truog, MD Children's Mercy Hospital Kansas City Principal Investigator: Uday Devaskar, MD University of California, Los Angeles Study Director: Haresh M Kirpalani, MD University of Pennsylvania Principal Investigator: Bradley Yoder, MD University of Utah
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