Safety During Use of Paediatric Triple Chamber Bag Formulas

Phase 3

Completed

• Conditions: Infant Nutrition Disorders; Infant, Premature, Diseases; Digestive System Disorders
• Interventions: Drug: Ped3CB

• Registration Number: NCT01304394
• Lead Sponsor: Baxter Healthcare Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2008-12
• Study Completion: 2009-06
• Status Verified: 2011-02
• Study First Submitted: 2011-02-23
• Study First Submitted QC: 2011-02-24
• Last Update Submitted: 2011-02-24
• Study First Posted: 2011-02-25
• Last Update Posted: 2011-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
parenteral nutrition solution	Ped3CB	-

Primary Outcome Measures

Name	Time	Method
Practical handling,ease of use and safety information (number of participants with adverse events)	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 Outcome Measures

Name	Time	Method
nutritional intakes received, change from baseline body weight	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.

Trial Locations

Locations (13)

Hôpital Necker; 🇫🇷 Paris, France

Hôpital Pontchaillou; 🇫🇷 Rennes, France

Hôpital HFME - Groupement Hospitalier Est; 🇫🇷 Bron, France

CHU Tivoli La Louvière; 🇧🇪 Louviere, Belgium

Hôpital Charles Nicolle; 🇫🇷 Rouen, France

Groupe Hospitalier Cochin-St Vincent de Paul; 🇫🇷 Paris, France

CHU de Poitiers; 🇫🇷 Poitiers, France

Hôpital de Hautepierre; 🇫🇷 Strasbourg, France

Maternité Régionale Adolphe Pinard; 🇫🇷 Nancy, France

CHR Citadelle; 🇧🇪 Liege, Belgium

CHU de Nantes; 🇫🇷 Nantes, France

CHU de Nancy- Hôpital d'Enfants; 🇫🇷 Nancy, France

Hôpital pédiatrique Gatien de Clocheville; 🇫🇷 Tours, France