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High Threshold Transfusion for Low Birth Weight Infant (TOP Trial)

Phase 3

Waitlist Available

Led By Bradley Yoder, MD

Research Sponsored by NICHD Neonatal Research Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 22-26 months corrected age

Awards & highlights

TOP Trial Summary

This trial is testing whether giving more transfusions to premature babies leads to better survival rates and brain development.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects from blood transfusions may include allergic reactions, infections, iron overload in the body, lung injury related to transfusion (TRALI), and immune system complications.

TOP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 22-26 months corrected age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 22-26 months corrected age

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 22-26 months corrected age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cognitive Delay

Death

Death or Neurodevelopmental Impairment

+4 more

Secondary outcome measures

Bronchopulmonary Dysplasia, Diagnosed on the Basis of the Need for Supplemental Oxygen After a Standardized Oxygen Reduction Test at 36 Weeks of Postmenstrual Age

Composite Cognitive Score Less Than 70

Composite Language Score Less Than 70

+20 more

TOP Trial Design

2Treatment groups

Active Control

Group I: High Threshold TransfusionActive Control1 Intervention

Transfusions will be administered using a higher threshold hemoglobin value.

Group II: Low Threshold TransfusionActive Control1 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

NICHD Neonatal Research NetworkLead Sponsor

59 Previous Clinical Trials

203,946 Total Patients Enrolled

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

3,833 Previous Clinical Trials

47,304,672 Total Patients Enrolled

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

1,963 Previous Clinical Trials

2,672,917 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you explain the present enrollment status for this clinical trial?

"The clinical trial mentioned is not currently enrolling patients. Although this is the case, there are 330 other active trials that potential participants can look into."

Answered by AI

Could you specify how many hospitals are part of this clinical trial?

"There are a 20 locations enrolling patients for this trial, some of which include RTI International in Detroit, Wayne State University in Dallas, and University of Texas Southwestern Medical Center at Dallas in Rochester."

Answered by AI