Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01304394 | Safety During Use of Paediatric Triple Chamber Bag Formulas | PHASE3 | COMPLETED | 161 | — | — | Feb 1, 2008 | Jun 1, 2009 | Feb 25, 2011 | 13 | Belgium, France |
Practical handling and ease of use were measured with questionnaires and a VAS assessment of the Ped3CB, which was to be compared with the standard practice of the pharmacy or nursing ward at each site. All AEs were recorded during study treatment through 2 days after the last infusion. Vital signs and adverse events were recorded daily for the 5 days of the study in all patients and during the optional treatment period (an additional 5 days) in preterm newborn infants.
| Arm | Type | Description |
|---|---|---|
| parenteral nutrition solution | OTHER | - |
| Name | Type | Description |
|---|---|---|
| Ped3CB | DRUG | The Ped3CB is a ready to use, triple-chamber bag containing a sterile, nonpyrogenic combination of amino acids (Primene®, Baxter) with electrolytes, glucose, and lipids (ClinOleic®, Baxter) in separate compartments for intravenous (IV) PN. The dosage, frequency and duration is dependent on patient's weight, age, clinical status as well as addition energy or protein given enterally/orally. |
Inclusion Criteria: * Hospitalized preterm newborn infants, term infants and toddlers, and children and adolescents requiring parenteral nutrition (PN) for at least 5 consecutive days. * Preterm infants were to require PN representing, at baseline, 80% of total estimated nutritional needs, and pati...