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Ped3CB · 1 trial · 3 indications
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...
Ped3CB is an investigational small molecule being developed for infant nutrition disorders. It is a pediatric triple chamber bag formula intended for use in infants, including premature infants, with digestive system disorders. The product is designed to address nutritional needs in this patient population.
Ped3CB is being developed by Baxter International Inc., a company traded on the New York Stock Exchange under the ticker symbol BAX. Baxter is conducting clinical research to evaluate the safety of this pediatric nutrition product in infants with nutrition disorders.
Ped3CB is in Phase 3 clinical development. It is an investigational product and has not been approved by regulatory authorities. A Phase 3 trial has been completed to assess its safety in the intended pediatric population.
Ped3CB has one completed Phase 3 clinical trial, identified as NCT01304394. This study, titled "Safety During Use of Paediatric Triple Chamber Bag Formulas," enrolled 161 participants and was conducted in Belgium and France. The trial was uncontrolled and not randomized or double-blinded.
Ped3CB is a pediatric triple chamber bag formula, as indicated by the clinical trial title. This means it is a nutrition product delivered in a bag with three separate chambers that are mixed before use. It is being studied for safety in infants with nutrition and digestive disorders.