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High Threshold Transfusion for Low Birth Weight Infant (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
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
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 moreSecondary 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 moreTOP 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
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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
3,848 Previous Clinical Trials
47,815,373 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,984 Previous Clinical Trials
2,681,369 Total Patients Enrolled
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