Tailored hormone dosing may spare preemies from blood transfusions
NCT ID NCT02075970
First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether personalized dosing of epoetin alfa—a lab-made hormone that boosts red blood cell production—can reduce or eliminate the need for blood transfusions in very low birth weight premature infants with neonatal anemia. Researchers will study how the drug behaves in the body and identify which infants are most likely to respond well. The goal is to develop a tailored treatment strategy that could transform care for these vulnerable newborns.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- epoetin alfa (Procrit), a lab-made hormone that stimulates red blood cell production
- What this could lead to
- If successful, this approach could reduce or eliminate the need for blood transfusions in many premature infants with anemia.
- What could go wrong
- This is a small, early-phase trial, so results may not apply to all infants. The drug may not work as hoped in some babies, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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33 people
The number who actually took part.
- Started
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Jun 2014
- Finished
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Dec 2019
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Up to 2 days
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Post-menstrual age at birth less than 37 wk; 2. birth weight of 1,001 to 1,500 g; 3. postnatal age \<48 h; 4. respiratory distress requiring ventilation; 5. signed consent by parent or guardian. Exclusion Criteria: 1. Anticipated survival \<72 h; 2. Hemolytic anemia due to alloimmune disease (including due to ABO), and other hemolytic disease processes; 3. Major anomalies that are life-threatening during the neonatal and infant periods (central nervous system, cardiac, metabolic chromosomal including, but not limited to, trisomies, deletions, and trinucleotide repeats); 4. Clinical seizures; 5. Congenital thrombotic or hemorrhagic conditions including disseminated intravascular coagulation; 6. Positive blood or spinal fluid bacterial or fungal culture, or other laboratory and/or clinical data indicative of sepsis, including TORCH infections, prior to 48 h of age; 7. Hematocrit \>50%; 8. Platelet count \>400,000 per µL in first 48 h of life; 9. Hypertension with systolic blood pressure \>100 mm Hg. 10. Any condition, in the opinion of the investigators, that would compromise the well being of the subject or the study, or prevent the subject from meeting or performing study requirements.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
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