Transfusion of Prematures Trial

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.

Conditions

• Infant, Newborn, Diseases
• Infant, Extremely Low Birth Weight
• Infant, Small for Gestational Age
• Bronchopulmonary Dysplasia (BPD)
• Anemia

Interventions

PROCEDURE

Liberal Cell Transfusion

PROCEDURE

Restricted red cell transfusion

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Michele C Walsh, MD · Case Western Reserve University, Rainbow Babies and Children's Hospital

• Abhik Das, PhD · RTI International

• Beena Sood, MD · Wayne State University

• Abbot R Laptook, MD · Brown University, Women & Infants Hospital of Rhode Island

• Michael Cotten, MD · Duke University

• Ravi Patel, MD · Emory University

• Greg Sokol, MD · Indiana University

• Krisa P Van Meurs, MD · Stanford University

• Brenda Poindexter, MD · Children's Hospital Medical Center, Cincinnati

• Waldemar A Carlo, MD · University of Alabama at Birmingham

• Kristi L Watterberg, MD · University of New Mexico

• Myra Wyckoff, MD · University of Texas, Southwestern Medical Center at Dallas

• Kathleen A Kennedy, MD, MPH · The University of Texas Health Science Center, Houston

• Carl T D'Angio, MD · University of Rochester

• Pablo Sanchez, MD · Research Institute at Nationwide Children's Hospital

• William Truog, MD · Children's Mercy Hospital Kansas City

• Uday Devaskar, MD · University of California, Los Angeles

• Haresh M Kirpalani, MD · University of Pennsylvania

• Bradley Yoder, MD · University of Utah

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Max Age

48 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-12-31

Primary Completion

2020-01-31

Completion

2025-04-29

Countries

• United States

Study Locations