Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Masked, Placebo Controlled Study to Assess the Safety and Efficacy of Darbepoetin Alfa Administered to Preterm Infants
Brief 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.


Options:
A: Arm Label: preterm ESA recipients; Type: N/A; Interventions: N/A | Arm Label: preterm controls; Type: N/A; Interventions: N/A | Arm Label: term controls; Type: N/A; Interventions: N/A
B: Arm Label: Darbepoetin alfa injection; Type: EXPERIMENTAL; Interventions: Drug: Darbepoetin Alfa Injection | Arm Label: erythropoietin alfa injection; Type: ACTIVE_COMPARATOR; Interventions: Drug: erythropoietin alfa injection | Arm Label: placebo/control; Type: PLACEBO_COMPARATOR; Interventions: Drug: sham injection | Intervention Type: DRUG; Name: Darbepoetin Alfa Injection; Assigned to Arm(s): Darbepoetin alfa injection | Intervention Type: DRUG; Name: erythropoietin alfa injection; Assigned to Arm(s): erythropoietin alfa injection | Intervention Type: DRUG; Name: sham injection; Assigned to Arm(s): placebo/control
C: Arm Label: Erythropoietin; Type: EXPERIMENTAL; Interventions: Drug: Recombinant human Erythropoietin | Arm Label: saline; Type: PLACEBO_COMPARATOR; Interventions: Drug: saline | Intervention Type: DRUG; Name: Recombinant human Erythropoietin; Assigned to Arm(s): Erythropoietin | Intervention Type: DRUG; Name: saline; Assigned to Arm(s): saline
D: Arm Label: G-CSF; Type: EXPERIMENTAL; Interventions: Drug: rh G-CSF | Arm Label: EPO; Type: EXPERIMENTAL; Interventions: Drug: rh EPO | Arm Label: G-CSF and EPO; Type: EXPERIMENTAL; Interventions: Drug: recombinant human G-CSF, and rhEPO, Drug: rh G-GSF and rh EPO together | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: recombinant human G-CSF, and rhEPO; Assigned to Arm(s): G-CSF and EPO | Intervention Type: DRUG; Name: rh G-CSF; Assigned to Arm(s): G-CSF | Intervention Type: DRUG; Name: rh EPO; Assigned to Arm(s): EPO | Intervention Type: DRUG; Name: rh G-GSF and rh EPO together; Assigned to Arm(s): G-CSF and EPO | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: B