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

April 21, 2025 updated by: Baxter Healthcare Corporation

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Numeta G13%E
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
Dose selected and dosing schedule are as deemed appropriate by the ordering attending physician in conjunction with the Investigator.
Active Comparator: Compounded Parenteral Nutrition (cPN) solution
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
Will be administered as institutional SOC procedure for the hospital.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in Weight (SDS or z-score) at Day 14
Time Frame: Baseline (first 24 hours of life) and 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Daily Protein Intake (g/kg/day)
Time Frame: Day 1 to 7
Nutritional intake from PN will be calculated as per any intravenous nutritional intake (Numeta G13%E, cPN and other sources). Nutritional intake from EN (Enteral Nutrition) will be calculated as per label for infant formula and human milk fortifier (HMF). (Protein = amino acids)
Day 1 to 7
Daily Energy Intake (kcal/kg/day)
Time Frame: Day 1 to 7
Nutritional intake from PN will be calculated as per any intravenous nutritional intake (Numeta G13%E, cPN and other sources). Nutritional intake from EN (Enteral Nutrition) will be calculated as per label for infant formula and human milk fortifier (HMF). Energy includes total calories, non-protein calories, glucose calories, lipid calories.
Day 1 to 7
Weekly Protein Intake (g/kg/week)
Time Frame: Week 1, Week 2, Week 3, Week 4
Nutritional intake from PN will be calculated as per any intravenous nutritional intake (Numeta G13%E, cPN and other sources). Nutritional intake from EN (Enteral Nutrition) will be calculated as per label for infant formula and human milk fortifier (HMF). (Protein = amino acids).
Week 1, Week 2, Week 3, Week 4
Weekly Energy Intake (kcal/kg/week)
Time Frame: Week 1, Week 2, Week 3, Week 4
Nutritional intake from PN will be calculated as per any intravenous nutritional intake (Numeta G13%E, cPN and other sources). Nutritional intake from EN (Enteral Nutrition) will be calculated as per label for infant formula and human milk fortifier (HMF). Energy includes total calories, non-protein calories, glucose calories, lipid calories.
Week 1, Week 2, Week 3, Week 4
Age (hours) when minimal weight is documented
Time Frame: Day 1
Measurement=hours.
Day 1
Maximum weight loss (%) from birth weight
Time Frame: Day 1 to Day 14
Measurement=percentage (%).
Day 1 to Day 14
Time (hours) to regain birth weight
Time Frame: Day 1 to Day 14
Postnatal age (hours) when body weight is first documented above BW after maximal weight loss.
Day 1 to Day 14
Weight gain velocity up to Day 14
Time Frame: Day 1 to Day 14
Calculated by taking the difference between the weight at the end of treatment and the minimum weight recorded and dividing it by the total number of treatment days.
Day 1 to Day 14
Change from Baseline in Weight (SDS or z-score) at Day 7, 14, 21 and 28
Time Frame: Baseline, Day 7, Day 14, Day 21, Day 28
Standard deviation score (SDS or z-score).
Baseline, Day 7, Day 14, Day 21, Day 28
Change from Baseline in Length (SDS or z-score) at Day 7, 14, 21 and 28
Time Frame: Baseline, Day 7, Day 14, Day 21, Day 28
Standard deviation score (SDS or z-score).
Baseline, Day 7, Day 14, Day 21, Day 28
Change from Baseline in Head Circumference (SDS or z-score) at Day 7, 14, 21 and 28
Time Frame: Baseline, Day 7, Day 14, Day 21, Day 28
Standard deviation score (SDS or z-score).
Baseline, Day 7, Day 14, Day 21, Day 28
Weekly gain in Weight (g/kg/day) at Day 7, 14, 21 and 28
Time Frame: Day 7, Day 14, Day 21, Day 28
Measurement=g/kg/day.
Day 7, Day 14, Day 21, Day 28
Weekly gain in Length (cm/week) at Day 7, 14, 21 and 28
Time Frame: Day 7, Day 14, Day 21, Day 28
Measurement=cm/week.
Day 7, Day 14, Day 21, Day 28
Weekly gain in Head Circumference (cm/week) at Day 7, 14, 21 and 28
Time Frame: Day 7, Day 14, Day 21, Day 28
Measurement=cm/week.
Day 7, Day 14, Day 21, Day 28
Change from Baseline in Weight (SDS or z-score) at End of study
Time Frame: Baseline up to Week 40
Measurement=Standard deviation score (SDS or z-score). End of Study=discharge or maximum 40 weeks post-menstrual age.
Baseline up to Week 40
Change from Baseline in Length (SDS or z-score) at End of study
Time Frame: Baseline up to Week 40
Measurement=Standard deviation score (SDS or z-score).
Baseline up to Week 40
Change from Baseline in Head Circumference (SDS or z-score) at End of study
Time Frame: Baseline up to Week 40
Measurement=Standard deviation score (SDS or z-score).
Baseline up to Week 40
Gain in Weight (g/kg/week) from Baseline to End of study
Time Frame: Baseline up to Week 40
Measurement=g/kg/week
Baseline up to Week 40
Gain in Length (cm/week) from Baseline to End of study
Time Frame: Baseline up to Week 40
Measurement=cm/week.
Baseline up to Week 40
Gain in Head Circumference (cm/week) from Baseline to End of study
Time Frame: Baseline up to Week 40
Measurement=cm/week.
Baseline up to Week 40
Number of Clinical Characteristics by Type
Time Frame: Week 1 up to Week 40
Including in-hospital deaths, necrotizing enterocolitis (NEC), late onset sepsis (LOS), bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), retinopathy of prematurity (ROP), and cholestasis
Week 1 up to Week 40
Duration of Clinical Characteristics by Type
Time Frame: Week 1 up to Week 40
Including mechanical ventilation duration, PN duration, antibiotic duration, and in-hospital length of stay (LoS)
Week 1 up to Week 40
Adverse Events of special interest (AESIs)
Time Frame: Week 1 up to Week 40
Week 1 up to Week 40

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baxter Healthcare Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BXU512338

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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