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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-001378-97 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| parenteral nutrition solution | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | measurements were taken on day 0-5 and up to day 10 on preterms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacques Rigo, MD, PhD | CHR Citadelle | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHR Citadelle | Liège | Belgium | ||||
| CHU Tivoli La Louvière |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33006765 | Derived | 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. |
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| ID | Term |
|---|---|
| D007228 | Infant Nutrition Disorders |
| D007235 | Infant, Premature, Diseases |
| D004066 | Digestive System Diseases |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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|
| Louvière |
| Belgium |
| Hôpital HFME - Groupement Hospitalier Est | Bron | France |
| CHU de Nancy- Hôpital d'Enfants | Nancy | France |
| Maternité Régionale Adolphe Pinard | Nancy | France |
| CHU de Nantes | Nantes | France |
| Groupe Hospitalier Cochin-St Vincent de Paul | Paris | France |
| Hôpital Necker | Paris | France |
| CHU de Poitiers | Poitiers | France |
| Hôpital Pontchaillou | Rennes | France |
| Hôpital Charles Nicolle | Rouen | France |
| Hôpital de Hautepierre | Strasbourg | France |
| Hôpital pédiatrique Gatien de Clocheville | Tours | France |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |