Table 11

Characteristics of the studies, pharmacokinetics and dose recommendations related to phenobarbital

StudynPNAWeightTypeGroupModelModalityAdministered doseVdCLt1/2 (hours)Recommended dose
Michaličková et al,34 Czech Republic1323.21RNeonates1-compartment with NONMEMVV–VALD: 7.5 mg/kg (8.5–16 mg/kg)
MD: 6.9 mg/kg/day (4.5–8.5 mg/kg/day)
2.72 L0.0096 L/hourIn the first 12 days of ECMO with a regimen of an LD of 20 mg/kg and an MD of 4 mg/kg/day divided in two doses with an increase of 0.25 mg/kg every 12 hours during ECMO.
Thibault et al,36 USA12/37*5 (0–26)3.2 (1.3–3.8)RNeonates1-compartment with first-order elimination with NONMEMVV–VALD: 15–20 mg/kg
MD: 3–6 mg/kg/day
(normalisation of albumin values from 2.5 mg/dL to 3.5 mg/dL decreased the estimated volume by 13%)
(over the first 20 days of life)
LD of 30 mg/kg achieved goal peak concentration. MD of 4–5 mg/kg/day sustained goal trough concentration.
  • Boldfaced fonts represent comparisons with controls within the same study. In other studies, they represent comparisons with non-ECMO neonates from a different published study.

  • *Number of patients undergoing only ECMO circuit.

  • CL, clearance; ECMO, extracorporeal membrane oxygenation; LD, loading dose; MD, maintenance dose; NONMEM, non-linear mixed-effects modelling; PNA, postnatal age; R, retrospective; t1/2, elimination half-life; VA, veno-arterial; Vd, volume of distribution; VV, veno-venous.