Table 1.
Conventional formulation of parenteral nutrition bags prepared in our NICU for our study and associated with continuous and discontinuous infused drugs. Particulate matter is expressed as mean ± standard deviations.
| Component | Protocol 1 | Protocol 2 | Particulate matter (number of particles per mL for sizes ≥10 µm; ≥25 µm)* in each component |
|---|---|---|---|
| Conventional formulation | |||
| 50% dextrosea | 3 mL | 15 mL | 8.1 ± 3.5; 0.5 ± 0.3 |
| Amino acidsb | 22 mL | 30 mL | 30.2 ± 3.9; 0.9 ± 0.8 |
| Water for injectionc | 17 mL | 37 mL | 7.2 ± 3.6; 0.4 ± 0.3 |
| Calcium gluconated | 3.6 mL | 4.5 mL | 8.9 ± 0.3; 0.1 ± 0.1 |
| Potassium chlorided | 0.3 mL | 0.7 mL | 22.9 ± 4.2; 1.0 ± 0.3 |
| Magnesium chloridee | 0.5 mL | 0.6 mL | 17.8 ± 1.8; 0.8 ± 0.4 |
| Glucose-1-phosphatef | 0.8 mL | 2.5 mL | 20.0 ± 7.6; 0.4 ± 0.7 |
| Trace elementsg | 0.6 mL | 0.7 mL | 48.8 ± 14.3; 0.8 ± 0.4 |
| L-carnitineh | 0.1 mL | 0.1 mL | 7.2 ± 0.5; 0.4 ± 0.1 |
| Total volume | 48.1 mL | 91.3 mL | |
| Continuous and discontinuous drug infusion | |||
| Sodium heparinei | 0.2 mL | 0.2 mL | 32.0 ± 2.1; 0.9 ± 0.4 |
| Dopamine chloride | 1 000 µg/24 h | 24.1 ± 3.4; 0.1 ± 0.1 | |
| Vitamine K | 1 mg/24 h | 17.1 ± 1.1; 0.5 ± 0.2 | |
| Caffeine citrate | 5 mg/24 h for 30 min | 22.7 ± 3.2; 0.8 ± 0.2 | |
| Hydrocortisone hemisuccinate | 0.5 mg/24 h bolus dose | 61.4 ± 1.8; 1.2 ± 0.6 | |
| Fluconazole | 5 mg/72 h for 1 h | 19.3 ± 5.7; 0.3 ± 0.2 | |
aMacoflex Macopharma (Mouvaux, France).
bPrimène Baxter (Maurepas, France).
cViaflo Baxter (Maurepas, France)
dProamp Aguettant (Lyon, France).
eLavoisier (Paris, France).
fPhocytan Aguettant (Lyon, France).
gAguettant (Lyon, France).
hLevocarnil Sigma-Tau (Issy-les-Moulineaux, France).
iChoay Sanofi-Aventis (Paris, France). 5 000 UI/mL sodium heparin was directly added to the parenteral nutrition bags.
*According to the USP and EP, the average number of sub-visible particles is <6,000 per container for particle sizes ≥10 µm and <600/container for particle sizes ≥25 µm. Tests showed that all components of the BPN bags present particulate contamination in accordance with the specifications of the Pharmacopoeia. Particulate matter was counted using the APSS-2000 instrument.