Red Cell Transfusions for Premature Infants

(TOP Trial)

Recruiting at19 trial locations

Overseen by Ravi Patel, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: NICHD Neonatal Research Network

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Abbot R Laptook, MD

Principal Investigator

Brown University, Women & Infants Hospital of Rhode Island

Krisa P Van Meurs, MD

Principal Investigator

Stanford University

Waldemar A Carlo, MD

Principal Investigator

University of Alabama at Birmingham

Kristi L Watterberg, MD

Principal Investigator

University of New Mexico

Myra Wyckoff, MD

Principal Investigator

University of Texas, Southwestern Medical Center at Dallas

C. Michael Cotten, MD

Principal Investigator

Duke University

Michele C Walsh, MD MS

Principal Investigator

Case Western Reserve University, Rainbow Babies and Children's Hospital

Carl T D'Angio, MD

Principal Investigator

University of Rochester

Pablo Sanchez, MD

Principal Investigator

Research Institute at Nationwide Children's Hospital

Bradley Yoder, MD

Principal Investigator

University of Utah

Ravi Patel, MD

Principal Investigator

Emory University

Abhik Das, PhD

Principal Investigator

RTI International

Haresh M Kirpalani, MD

Principal Investigator

University of Pennsylvania

Beena Sood, MD

Principal Investigator

Wayne State University

William Truog, MD

Principal Investigator

Children's Mercy Hospital Kansas City

Uday Devaskar, MD

Principal Investigator

University of California, Los Angeles

Kathleen A Kennedy, MD MPH

Principal Investigator

The University of Texas Health Science Center, Houston

Brenda Poindexter, MD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Greg Sokol, MD

Principal Investigator

Indiana University

Eligibility Criteria

The TOP trial is for extremely low birth weight infants with a gestational age of 22-28 weeks, admitted to the NICU within 48 hours of life, and weighing less than or equal to 1000 grams. Infants who've had prior transfusions (beyond first 6 hours), received erythropoietin, have congenital conditions affecting survival/neurodevelopment, severe acute conditions, or whose parents cannot attend follow-up are excluded.

Inclusion Criteria

Gestational age at least 22 weeks but less than 29 weeks

Admitted to the NICU within 48 hours of life

Birth weight less than or equal to 1000 grams.

Exclusion Criteria

Infant has received erythropoietin prior to randomization, or is intended to receive erythropoietin through the neonatal course

You have had a blood transfusion while still in your mother's womb.

Lack of parental consent

Treatment Details

Interventions

• Liberal Cell Transfusion (Other)
• Restricted red cell transfusion (Other)

Trial Overview This study tests if higher hemoglobin thresholds in red cell transfusions for very small premature babies can improve survival and neurodevelopment at around two years old. Babies will be randomly assigned to receive either more frequent 'liberal' or less frequent 'restricted' blood transfusions.

Participant Groups

Group I: High Threshold Transfusion Active Control 1 Intervention

Transfusions will be administered using a higher threshold hemoglobin value.

Group II: Low Threshold Transfusion Active Control 1 Intervention

Transfusions will be administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group

Who Is Running the Clinical Trial?

NICHD Neonatal Research Network

Lead Sponsor

Trials

62

Recruited

209,000+

Dr. Diana W. Bianchi

NICHD Neonatal Research Network

Chief Executive Officer since 2016

MD from Tufts University School of Medicine

Dr. Krisa Van Meurs

NICHD Neonatal Research Network

Chief Medical Officer since 2023

MD from Stanford University School of Medicine

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Dr. Diana W. Bianchi

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

Chief Executive Officer since 2016

MD from Stanford University

Dr. Alison Cernich

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

Chief Medical Officer since 2020

PhD in Clinical Psychology from University of Maryland