5 results
2.1.1 Primary Objective1.Evaluate the LDL-C-lowering effects of ERN/LRPT/SIM 2 g/20 mg compared to ERN/LRPT 2 g coadministered with simvastatin 20 mg.Hypothesis: ERN/LRPT/SIM 2 g/20 mg is equivalent to ERN/LRPT 2 g coadministered with simvastatin 20…
To test whether stabilisation of preterm infants with PBCC using the Concord is at least as effective when compared to the standard approach using the standard resuscitation table.
To compare the effect of umbilical cord clamping after cardiopulmonary stabilisation (Physiological Based Cord Clamping; PBCC) to standard care (Time Based Cord Clamping; TBCC) on intact survival and health care costs in preterm infants.
Primary objectives:# Safety Lead-in Phase: To assess the safety and tolerability, and to establish an RP2D if applicable, of treatment combinations that have not been evaluated in a separate study.# Efficacy Phase: To assess the safety and…
Primary objectives:# Safety Lead-in Phase: To assess the safety and tolerability, and to establish an RP2D if applicable, of treatment combinations that have not been evaluated in a separate study.# Efficacy Phase: To assess the safety and…