Clinical trial NCT01304394: Safety During Use of Paediatric Triple Chamber Bag Formulas
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infant Nutrition Disorders
Infant, Premature, Diseases
Digestive System Disorders
Keywords: Parenteral Nutrition
Multi Chamber Bag
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2011-02-25
Enrollment: 161
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Practical handling,ease of use and safety information (number of participants with adverse events)
timeFrame: 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
Secondary outcomes:
measure: nutritional intakes received, change from baseline body weight
timeFrame: measurements were taken on day 0-5 and up to day 10 on preterms
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: CHR Citadelle
city: Louviere
country: Belgium
facility: CHU Tivoli La Louvière
city: Bron
country: France
facility: Hôpital HFME - Groupement Hospitalier Est
city: Nancy
country: France
facility: CHU de Nancy- Hôpital d'Enfants
city: Nancy
country: France
facility: Maternité Régionale Adolphe Pinard
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Groupe Hospitalier Cochin-St Vincent de Paul
city: Paris
country: France
facility: Hôpital Necker
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: Strasbourg
country: France
facility: Hôpital de Hautepierre
city: Tours
country: France
facility: Hôpital pédiatrique Gatien de Clocheville
Study officials:
affiliation: CHR Citadelle
name: Jacques Rigo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.