Status:
WITHDRAWN
Efficacy and Safety of Numeta G13%E Compared to Compounded Parenteral Nutrition in Preterm Neonates
Lead Sponsor:
Baxter Healthcare Corporation
Conditions:
Malnutrition, Infant
Enteral Feeding Intolerance
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE3
Brief Summary
Preterm (PT, born before 37 weeks of gestation) birth complications are the leading causes of death among children aged under 5 years globally, with nearly one million infant deaths reported in 2013. ...
Eligibility Criteria
Inclusion
- PT birth (\>28 and \< 37 weeks of gestation)
- Postnatal age \< 48 hours
- Medical determination of PN requirement made by the attending physician in conjunction with the Investigator
- An anticipated PN duration after inclusion of at least 5 days
- Requirement for ≥ 80 % of energy intake from PN at inclusion (PN initiation)
- Written ICF signed by the patient's legal representative
Exclusion
- Neonates born \< 28 and ≥ 37 weeks of gestation
- Neonates with a life expectancy \<1 week, which means with very severe critical illness implying foreseeable intercurrent events that could jeopardize the subject's primary outcome assessment including neonates with severe septic shock;
- Neonates requiring or anticipated to undergo extracorporeal membrane oxygenation treatment;
- Neonates with inborn error of metabolism including congenital abnormality of the amino acid metabolism or a family history of such disease;
- Neonates with hyperkalemia \> 5.5 mmol/L at inclusion
- Neonates with known severe pathologically elevated plasma concentrations of electrolyte at inclusion including hyperchloridemia \> 120 mmol/L;
- Neonates with known severe hyperglycemia \>13.9 mmol/L (250 mg/dL) at inclusion;
- Neonates with demonstrated severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia \> 4.5 mmol/L (400 mg/dL) at inclusion;
- Neonates with known severe liver failure including plasma ALT (GPT) concentration \> 2 times the upper reference limit or conjugated (direct) bilirubin \> 34 µmol/L (\> 2 mg/dL) at inclusion;
- Neonates with anuria and known severe renal disorder including plasma creatinine concentration \> 2 times the upper reference limit at inclusion;
- Neonates with bleeding and severe coagulation disorders including platelet count \< 20×109/L at inclusion;
- Neonates with general contraindications to infusion therapy: acute pulmonary edema, overhydration;
- Neonates with known allergy to egg, soy bean or peanut proteins or to any of their active ingredients or excipients;
- Neonates undergoing concomitant treatment with ceftriaxone, even if separate infusion lines are used;
- Neonates undergoing participation in another investigational clinical study at study enrollment.
Key Trial Info
Start Date :
August 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06894446
Start Date
August 20 2021
End Date
May 30 2022
Last Update
April 24 2025
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