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Safety During Use of Paediatric Triple Chamber Bag Formulas

Primary Purpose

Infant Nutrition Disorders, Infant, Premature, Diseases, Digestive System Disorders

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ped3CB
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant Nutrition Disorders focused on measuring Parenteral Nutrition, Multi Chamber Bag

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • CHR Citadelle
  • CHU Tivoli La Louvière
  • Hôpital HFME - Groupement Hospitalier Est
  • CHU de Nancy- Hôpital d'Enfants
  • Maternité Régionale Adolphe Pinard
  • CHU de Nantes
  • Groupe Hospitalier Cochin-St Vincent de Paul
  • Hôpital Necker
  • CHU de Poitiers
  • Hôpital Pontchaillou
  • Hôpital Charles Nicolle
  • Hôpital de Hautepierre
  • Hôpital pédiatrique Gatien de Clocheville

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

parenteral nutrition solution

Arm Description

Outcomes

Primary Outcome Measures

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

nutritional intakes received, change from baseline body weight
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.

Full Information

First Posted
February 23, 2011
Last Updated
February 24, 2011
Sponsor
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01304394
Brief Title
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

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Baxter Healthcare Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Nutrition Disorders, Infant, Premature, Diseases, Digestive System Disorders
Keywords
Parenteral Nutrition, Multi Chamber Bag

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
parenteral nutrition solution
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Ped3CB
Intervention Description
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 Outcome Measure Information:
Title
Practical handling,ease of use and safety information (number of participants with adverse events)
Description
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.
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
Secondary Outcome Measure Information:
Title
nutritional intakes received, change from baseline body weight
Description
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.
Time Frame
measurements were taken on day 0-5 and up to day 10 on preterms

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Rigo, MD, PhD
Organizational Affiliation
CHR Citadelle
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR Citadelle
City
Liege
Country
Belgium
Facility Name
CHU Tivoli La Louvière
City
Louviere
Country
Belgium
Facility Name
Hôpital HFME - Groupement Hospitalier Est
City
Bron
Country
France
Facility Name
CHU de Nancy- Hôpital d'Enfants
City
Nancy
Country
France
Facility Name
Maternité Régionale Adolphe Pinard
City
Nancy
Country
France
Facility Name
CHU de Nantes
City
Nantes
Country
France
Facility Name
Groupe Hospitalier Cochin-St Vincent de Paul
City
Paris
Country
France
Facility Name
Hôpital Necker
City
Paris
Country
France
Facility Name
CHU de Poitiers
City
Poitiers
Country
France
Facility Name
Hôpital Pontchaillou
City
Rennes
Country
France
Facility Name
Hôpital Charles Nicolle
City
Rouen
Country
France
Facility Name
Hôpital de Hautepierre
City
Strasbourg
Country
France
Facility Name
Hôpital pédiatrique Gatien de Clocheville
City
Tours
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33006765
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.
Results Reference
derived

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Safety During Use of Paediatric Triple Chamber Bag Formulas

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