Transfusion of Prematures Trial (NCT01702805) | Clinical Trial Compass
CompletedNot Applicable
Transfusion of Prematures Trial
United States1,824 participantsStarted 2012-12
Plain-language 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.
Who can participate
Age range
48 Hours
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Birth weight less than or equal to 1000 grams.
* Gestational age at least 22 weeks but less than 29 weeks
* Admitted to the NICU within 48 hours of life
Exclusion Criteria:
* Considered nonviable by the attending neonatologist
* Cyanotic congenital heart disease
* Parents opposed to the transfusion of blood
* Parents with hemoglobinopathy or congenital anemia
* In-utero fetal transfusion
* Twin-to-twin transfusion syndrome
* Isoimmune hemolytic disease
* Lack of parental consent
* Severe acute hemorrhage, acute shock, sepsis with coagulopathy, or need for perioperative transfusion.
* Prior blood transfusion on clinical grounds beyond the first 6 hours of life
* Infant has received erythropoietin prior to randomization, or is intended to receive erythropoietin through the neonatal course
* Congenital condition, other than premature birth, that adversely affects life expectancy or neurodevelopment.
* High probability that the family is socially disorganized to the point of being unable to attend follow-up at 22-26 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.