Safety During Use of Paediatric Triple… | Clinical Trial

Key information

Conditions

Infant Nutrition Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Digestive System Disorders Hyperphagia Infant, Newborn, Diseases Infant, Premature, Diseases Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHR Citadelle, Liège, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

Practical handling,ease of use and safety information (number of participants with adverse events)

Time frame: measurements were taken on day 0-5 and up to day 10 on preterms and through 2 days after the last infusion of study product

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.

Secondary outcomes

nutritional intakes received, change from baseline body weight

Time frame: measurements were taken on day 0-5 and up to day 10 on preterms

Nutritional intakes, particularly the Ped3CB dose, were recorded daily during the treatment period.

Body weight was measured and recorded daily. Changes from baseline to end of treatment were evaluated.

Sponsors and collaborators

Lead sponsor

Baxter Healthcare Corporation

Industry

Registry information

Official study title

Safety During Use of Paediatric Triple Chamber Bag Formulas, Administered IV at a Weight Dependant Dose During 5 Consecutive Days, in Paediatric Patients up to 18 Years Requiring Parenteral Nutrition.

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2009
First posted: Feb 25, 2011
Registry last updated: Feb 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed