Malnutrition, InfantPhase 3NCT06894446

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

A Phase 3 study testing Numeta G13%E and Compounded Parenteral Nutrition (cPN) solution in people with Malnutrition, Infant and Enteral Feeding Intolerance, run by Baxter Healthcare Corporation.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial summary

Who is it for?: Ages 0 to 24 hoursHealthy volunteers can take part
Conditions the study is for: Malnutrition, Infant, Enteral Feeding Intolerance
What is being tested?: Numeta G13%E and Compounded Parenteral Nutrition (cPN) solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: 20 Aug 2021to 30 May 2022
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 0 to 24 hours
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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;

Show all 15Show fewer

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.

About this study

Official title: 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.

Conditions: Malnutrition, Infant, Enteral Feeding Intolerance
Being tested: Numeta G13%E, Compounded Parenteral Nutrition (cPN) solution
Keywords: parenteral nutrition
Medical subject headings: Infant Nutrition Disorders, Hyperphagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06894446
Study group	Role	What they receive
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. Receives: 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. Receives: Dietary Supplement: Compounded Parenteral Nutrition (cPN) solution

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline (first 24 hours of life) and Day 14

Secondary outcomes (23)

Daily Protein Intake (g/kg/day)
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)
Measured: Day 1 to 7
Daily Energy Intake (kcal/kg/day)
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.
Measured: Day 1 to 7
Weekly Protein Intake (g/kg/week)
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).
Measured: Week 1, Week 2, Week 3, Week 4
Weekly Energy Intake (kcal/kg/week)
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.
Measured: Week 1, Week 2, Week 3, Week 4
Age (hours) when minimal weight is documented
Measurement=hours.
Measured: Day 1
Maximum weight loss (%) from birth weight
Measurement=percentage (%).
Measured: Day 1 to Day 14
Time (hours) to regain birth weight
Postnatal age (hours) when body weight is first documented above BW after maximal weight loss.
Measured: Day 1 to Day 14
Weight gain velocity up 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.
Measured: Day 1 to Day 14
Change from Baseline in Weight (SDS or z-score) at Day 7, 14, 21 and 28
Standard deviation score (SDS or z-score).
Measured: 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
Standard deviation score (SDS or z-score).
Measured: 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
Standard deviation score (SDS or z-score).
Measured: Baseline, Day 7, Day 14, Day 21, Day 28
Weekly gain in Weight (g/kg/day) at Day 7, 14, 21 and 28
Measurement=g/kg/day.
Measured: Day 7, Day 14, Day 21, Day 28
Weekly gain in Length (cm/week) at Day 7, 14, 21 and 28
Measurement=cm/week.
Measured: Day 7, Day 14, Day 21, Day 28
Weekly gain in Head Circumference (cm/week) at Day 7, 14, 21 and 28
Measurement=cm/week.
Measured: Day 7, Day 14, Day 21, Day 28
Change from Baseline in Weight (SDS or z-score) at End of study
Measurement=Standard deviation score (SDS or z-score). End of Study=discharge or maximum 40 weeks post-menstrual age.
Measured: Baseline up to Week 40
Change from Baseline in Length (SDS or z-score) at End of study
Measurement=Standard deviation score (SDS or z-score).
Measured: Baseline up to Week 40
Change from Baseline in Head Circumference (SDS or z-score) at End of study
Measurement=Standard deviation score (SDS or z-score).
Measured: Baseline up to Week 40
Gain in Weight (g/kg/week) from Baseline to End of study
Measurement=g/kg/week
Measured: Baseline up to Week 40
Gain in Length (cm/week) from Baseline to End of study
Measurement=cm/week.
Measured: Baseline up to Week 40
Gain in Head Circumference (cm/week) from Baseline to End of study
Measurement=cm/week.
Measured: Baseline up to Week 40
Number of Clinical Characteristics by Type
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
Measured: Week 1 up to Week 40
Duration of Clinical Characteristics by Type
Including mechanical ventilation duration, PN duration, antibiotic duration, and in-hospital length of stay (LoS)
Measured: Week 1 up to Week 40
Adverse Events of special interest (AESIs)
Measured: Week 1 up to Week 40

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Aug 202130 May 2022

First posted25 Mar 2025
Study start20 Aug 2021 (estimated)
Primary completion30 May 2022 (estimated)
Study completion30 May 2022 (estimated)

Why it stopped: Business decision due to practice in China

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Malnutrition, InfantStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06894446
Sponsor's protocol ID: BXU512338
Status last verified: Apr 2025
First submitted: 19 Mar 2025
Last updated: 24 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Hospital-Based Prospective Cohort of Malnutrition Under 6-Month Study (HOSPIC-6-Study)
Malnutrition, Infant, Malnutrition
Active, not recruiting
Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
Infant Malnutrition, Light-For-Dates With Signs of Fetal Malnutrition
Recruiting
7-Day vs 1-Day Packaging for Small Quantity Lipid-Based Nutrient Supplements in Ghana (SQLNS:7D-1D Comparison)
Child Malnutrition
Not yet recruitingPhase 4
Effects of Maternal Multiple Micronutrient Supplementation During Lactation on Child Development in Ethiopia
Iodine Deficiency, Nutrition Poor
Not yet recruiting
The OK Daily Study
Infant Vitamin K Status, Vitamin K Deficiency Bleeding

All Malnutrition, Infant trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06894446
Acronym / sponsor ID: BXU512338
Conditions: Malnutrition, Infant, Enteral Feeding Intolerance
Keywords: parenteral nutrition
Phase: Phase 3
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Business decision due to practice in China
Enrolment: 0 participants (actual)
Lead sponsor: Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
Study start: 20 Aug 2021 (estimated)
Primary completion: 30 May 2022 (estimated)
Study completion: 30 May 2022 (estimated)
First posted: 25 Mar 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Numeta G13%E	Experimental	Dietary Supplement: Numeta G13%ERequired 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.
Compounded Parenteral Nutrition (cPN) solution	Active comparator	Dietary Supplement: Compounded Parenteral Nutrition (cPN) solutionRequired 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.

Who may qualify

Ages: 0 to 24 hours
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Numeta G13%EDose selected and dosing schedule are as deemed appropriate by the ordering attending physician in conjunction with the Investigator.	Dietary supplement	Numeta G13%E
Compounded Parenteral Nutrition (cPN) solutionWill be administered as institutional SOC procedure for the hospital.	Dietary supplement	Compounded Parenteral Nutrition (cPN) solution

Primary outcome

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.

23 secondary outcomes

Daily Protein Intake (g/kg/day)
Time frame: Day 1 to 7
Daily Energy Intake (kcal/kg/day)
Time frame: Day 1 to 7
Weekly Protein Intake (g/kg/week)
Time frame: Week 1, Week 2, Week 3, Week 4
Weekly Energy Intake (kcal/kg/week)
Time frame: Week 1, Week 2, Week 3, Week 4
Age (hours) when minimal weight is documented
Time frame: Day 1
Maximum weight loss (%) from birth weight
Time frame: Day 1 to Day 14
Time (hours) to regain birth weight
Time frame: Day 1 to Day 14
Weight gain velocity up to Day 14
Time frame: 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
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
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
Weekly gain in Weight (g/kg/day) at Day 7, 14, 21 and 28
Time frame: 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
Weekly gain in Head Circumference (cm/week) at Day 7, 14, 21 and 28
Time frame: 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
Change from Baseline in Length (SDS or z-score) at End of study
Time frame: 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
Gain in Weight (g/kg/week) from Baseline to End of study
Time frame: Baseline up to Week 40
Gain in Length (cm/week) from Baseline to End of study
Time frame: Baseline up to Week 40
Gain in Head Circumference (cm/week) from Baseline to End of study
Time frame: Baseline up to Week 40
Number of Clinical Characteristics by Type
Time frame: Week 1 up to Week 40
Duration of Clinical Characteristics by Type
Time frame: Week 1 up to Week 40
Adverse Events of special interest (AESIs)
Time frame: Week 1 up to Week 40

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.

Related trials for Malnutrition, Infant

RecruitingObservational study
Hospital-Based Prospective Cohort of Malnutrition Under 6-Month Study (HOSPIC-6-Study)
Malnutrition, Infant, Malnutrition
Active, not recruiting
Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
Infant Malnutrition, Light-For-Dates With Signs of Fetal Malnutrition
Recruiting
7-Day vs 1-Day Packaging for Small Quantity Lipid-Based Nutrient Supplements in Ghana (SQLNS:7D-1D Comparison)
Child Malnutrition
Not yet recruitingPhase 4
Effects of Maternal Multiple Micronutrient Supplementation During Lactation on Child Development in Ethiopia
Iodine Deficiency, Nutrition Poor
Not yet recruiting
The OK Daily Study
Infant Vitamin K Status, Vitamin K Deficiency Bleeding

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Numeta G13%E and Compounded Parenteral Nutrition (cPN) solution in people with Malnutrition, Infant and Enteral Feeding Intolerance, run by Baxter Healthcare Corporation.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Weight (SDS or z-score) at Day 14 (time frame: Baseline (first 24 hours of life) and Day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06894446.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.