NCT06894446

Efficacy and Safety of Numeta G13%E Compared to Compounded Parenteral Nutrition in Preterm Neonates

Prospective, Multicenter, Open-label, Randomized (1:1 Ratio), Controlled, Parallel Study Comparing Baxter Numeta G13%E to Compounded Parenteral Nutrition (cPN) Solution to Evaluate the Efficacy and Safety of Numeta G13%E in Preterm Neonates

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 0 Hours – 24 Hours
• Healthy volunteers: Accepted

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. Preterm infants are born with limited nutrient stores, while birth occurs when the nutritional requirements are the highest in human life. Due to the immaturity of their gastrointestinal system, parenteral nutrition (PN) is usually required during the first weeks of life, especially in very low birth weight (VLBW) infants. Despite the availability of national and international guidelines, the initiation of PN is frequently not compliant with current recommendations, especially during the first days of life. In China, like in many other parts of the world, insufficient nutritional supply during hospital stay plays an important role in the postnatal growth restriction (PNGR) of PT infants. Several authors have recently shown that the use of standardized PN formulations can enable optimal early PN intake and can support improved growth rate without adverse consequences in PT infants. Guidelines recommend that standard PN solutions should generally be used over individualized PN solutions in the majority of pediatric and newborn patients, including VLBW infants. They also recommended that individually tailored PN solution should generally be used when the nutritional requirements cannot be met by the available range of standard PN formulations. Given the challenges of optimizing PN practice in PT infants, the aim of this study is to demonstrate non-inferiority of Numeta G13%E to classic compounding practice used for Chinese PT neonates. Please note: Secondary safety endpoints that include Adverse Events (AE) and abnormal blood results will be captured in AE section.

Conditions

• Malnutrition, Infant
• Enteral Feeding Intolerance

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Numeta G13%E	Dose selected and dosing schedule are as deemed appropriate by the ordering attending physician in conjunction with the Investigator.
DIETARY_SUPPLEMENT	Compounded Parenteral Nutrition (cPN) solution	Will be administered as institutional SOC procedure for the hospital.

Timeline

• Start date: 2021-08-20
• Primary completion: 2022-05-30
• Completion: 2022-05-30
• First posted: 2025-03-25
• Last updated: 2025-04-24