Red Cell Transfusions for Premature Infants (TOP Trial)

Phase 3

Waitlist Available

Led By Waldemar A Carlo, 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

No Placebo-Only Group

Pivotal 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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cognitive Delay

Death

Death or Neurodevelopmental Impairment

+4 more

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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