Safety During Use of Paediatric Triple Chamber Bag Formulas

Baxter

Status and phase

Completed

Phase 3

Conditions

Infant, Premature, Diseases

Digestive System Disorders

Infant Nutrition Disorders

Treatments

Drug: Ped3CB

Study type

Interventional

Funder types

Industry

Identifiers

NCT01304394

2007-001378-97 (EudraCT Number)

Ped3CB/P01/06/Mu.B

Details and patient eligibility

About

The primary objective of this study was to provide daily information on the performance safety of the Ped3CB in practical therapeutic use in pediatric patients.

Enrollment

161 patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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 patients in the other groups (term infants toddlers; children) were to require PN representing, at baseline, at least 50% of total estimated nutritional needs.
Patient whose parents or legally authorized representative had provided signed written informed consent

Exclusion criteria

Patients with a life expectancy < 6 days or with a severe illness with foreseeable intercurrent events that could jeopardize the patient's participation in the study were not included in the study.
Patients with a diagnosis of shock, cardiac or renal failure with fluid overload, metabolic acidosis, respiratory failure, signs of sepsis, severe dyslipidemia, uncorrected metabolic disorders, severe sepsis, severe liver disease including cholestasis icterus, blood coagulation disorders and/or thrombophlebitis, acute myocardial infarction, or hypersensitivity to the active substance or any of the excipients of the test product, were not included in the study.
Patients with specific nutritional requirements that could not be met by Ped3CB formulas were also excluded.