Kurzfassung

This is a prospective, multicenter, double blind, placebo-controlled, two-arm parallel group phase 3 trial to evaluate the effect of early postnatal additional high dose oral VA supplementation of 5000 IU/kg/d versus placebo for 28 days in preventing BPD or death in ELBW infants.

There will be two groups, a “verum” and a “placebo” group, with 457 subjects in each group. Trial subjects are ELBW premature neonates whose parents have given Informed Consent and who comply with the trial’s...This is a prospective, multicenter, double blind, placebo-controlled, two-arm parallel group phase 3 trial to evaluate the effect of early postnatal additional high dose oral VA supplementation of 5000 IU/kg/d versus placebo for 28 days in preventing BPD or death in ELBW infants.

There will be two groups, a “verum” and a “placebo” group, with 457 subjects in each group. Trial subjects are ELBW premature neonates whose parents have given Informed Consent and who comply with the trial’s inclusion and exclusion criteria.

After confirmation of subjects eligibility for trial inclusion, they will be randomly assigned to either the treatment with the investigational medicinal product (IMP) or with the placebo for 28 days and assessed until 36+0 weeks PMA or date of discharge to home, whichever comes first.» weiterlesen» einklappen