DIVI: Darbepoetin Plus IV Iron in Preterm Infants

• Group 1. Oral iron

  Oral iron started on day 7 of life, adjusted every 2 weeks.

• Group 2

  Darbe 10 mcg/kg/week + LMW-ID 10 mg/kg x 1, retreat if ferritin < 76 mcg/L.

• Group 3

  Darbe 10 mcg/kg/week + LMW-ID 20 mg/kg x 1, retreat if ferritin < 76 mcg/L.

• Group 4

  Darbe 10 mcg/kg/week + FMX 10 mg/kg x 1, retreat if ferritin < 76 mcg/L.

• Group 5

  Darbe 10 mcg/kg/week + FMX 20 mg/kg x 1, retreat if ferritin < 76 mcg/L.

Primary

• Plasma Ferritin35-36 weeks PMA

• Number of IV iron doses required to maintain a ferritin level of > 75 ng/mLBirth to 36 weeks PMA

• Number of Blood transfusionsBirth to 36 weeks PMA

• Volume of blood transfusionsBirth to 36 weeks PMA

Secondary

• Number and percent of patients per group that remain transfusion freeBirth to 36 weeks PMA

• HematocritBirth to 36 weeks PMA

• Safety of IV ironBirth to 36 weeks PMA

• Early gut microbiome comparison between study groups4 weeks

• Rate of referral for Brainstem auditory evoked response36 weeks PMA

• Rate of pass/fail the General Movements Assessments (GMA)3 months corrected age

• Scores for the Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS)6 months corrected age

• Late gut microbiome comparison between study groups2 years corrected age