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NCT00334737 · ClinicalTrials.gov registry record · Phase 2
Darbepoetin Administration to Preterm Infants
A Phase 2 study, sponsored by University of New Mexico.
- Completed
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
NCT00334737 is a Phase 2 study that has completed, run by University of New Mexico. The registered enrollment target is 102 participants.
The verdict
NCT00334737, a Phase 2 study, has completed, sponsored by University of New Mexico.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
Study Summary
Infants born prematurely do not increase production of the primary red cell growth factor, erythropoietin (Epo), and often develop an anemia called the "anemia of prematurity." The anemia of prematurity is the most common anemia seen in neonates, and is due to a failure of Epo production. Human recombinant Epo (rHuEpo), given three to five times a week, is successful in treating the anemia of prematurity. A slightly modified, long-acting version of rHuEpo, called darbepoetin alfa (darbepoetin), is now available and has proven effective in increasing hematocrit (red blood cell levels) in adults. In addition to its red cell stimulating properties, recent evidence has shown that rHuEpo is protective in the developing or injured brain. We have designed a randomized, masked, placebo-controlled study to determine the safety and short and long term efficacy of darbepoetin. At this time, darbepoetin has been studied primarily in adults and pediatric patients, but there is evidence from pilot studies that darbepoetin would be useful in the neonatal setting as well. It also may well improve neurodevelopmental outcomes in preterm neonates. We hypothesize that: 1. The administration of darbepoetin to preterm infants 500 to 1,250 grams birth weight will result in increased reticulocyte counts and decreased transfusions compared to placebo; and 2. The administration of darbepoetin will be associated with an increased mental developmental index at 18-22 months compared to placebo.
Interventions
- DRUG sham injection
- DRUG Darbepoetin Alfa Injection
- DRUG erythropoietin alfa injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2006-06 |
| Est. Completion | 2014-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00334737
The ClinicalTrials.gov registry entry for NCT00334737 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of New Mexico, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which sham injection is the first listed.
NCT00334737 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00334737 about?
NCT00334737 is a clinical study titled "Darbepoetin Administration to Preterm Infants". Infants born prematurely do not increase production of the primary red cell growth factor, erythropoietin (Epo), and often develop an anemia called the "anemia of prematurity." The anemia of prematurity is the most common anemia seen in neonates, and is due to a failure of Epo production. Human reco...
What is the current status of trial NCT00334737?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2006-06. Estimated completion is 2014-06.
What interventions are being tested in trial NCT00334737?
The interventions under investigation include: sham injection (DRUG), Darbepoetin Alfa Injection (DRUG), erythropoietin alfa injection (DRUG).
Who is sponsoring clinical trial NCT00334737?
This trial is sponsored by University of New Mexico, which has 168 total clinical trials registered on ClinicalTrials.gov.
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