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

NCT06894446 | Withdrawn Phase 3

• 1 other identifier: BXU512338
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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. 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

Keywords

parenteral nutrition

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Weight (SDS or z-score) at Day 14

  The change in weight standard deviation score (SDS or z-score) from birth to 14 days of life, calculated according to reference growth chart developed to assess the growth of preterm infants. To be included in the primary endpoint analysis, patients must minimally receive PN up to Day 5.

  Baseline (first 24 hours of life) and Day 14

Secondary Outcomes (23)

• Daily Protein Intake (g/kg/day)

  Day 1 to 7

• Daily Energy Intake (kcal/kg/day)

  Day 1 to 7

• Weekly Protein Intake (g/kg/week)

  Week 1, Week 2, Week 3, Week 4

• Weekly Energy Intake (kcal/kg/week)

  Week 1, Week 2, Week 3, Week 4

• Age (hours) when minimal weight is documented

  Day 1

Study Arms (2)

Numeta G13%E

EXPERIMENTAL

Required PN intake will be determined daily based on clinical condition, calculated nutritional need and enteral nutrition (EN) intake by the attending physician in conjunction with the Investigator. Patients will receive Numeta G13%E until standard of care (SOC) discontinuation of PN, as decided by the attending physician in conjunction with the Investigator for the best interest of the patient or for a maximum of 28 days.

Dietary Supplement: Numeta G13%E

Compounded Parenteral Nutrition (cPN) solution

ACTIVE COMPARATOR

Required PN intake will be determined daily based on clinical condition, calculated nutritional need and enteral nutrition (EN) intake by the attending physician in conjunction with the Investigator. Patients will receive cPN until standard of care (SOC) discontinuation of PN, as decided by the attending physician in conjunction with the Investigator for the best interest of the patient or for a maximum of 28 days.

Dietary Supplement: Compounded Parenteral Nutrition (cPN) solution

Interventions

Numeta G13%E DIETARY_SUPPLEMENT

Dose selected and dosing schedule are as deemed appropriate by the ordering attending physician in conjunction with the Investigator.

Numeta G13%E

Compounded Parenteral Nutrition (cPN) solution DIETARY_SUPPLEMENT

Will be administered as institutional SOC procedure for the hospital.

Compounded Parenteral Nutrition (cPN) solution

Eligibility Criteria

• Age: 0 Hours - 24 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Written ICF signed by the patient's legal representative

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

MeSH Terms

Conditions

Infant Nutrition Disorders; Hyperphagia

Interventions

Solutions

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 25, 2025
• Study Start: August 20, 2021
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: April 24, 2025

Record last verified: 2025-04