A Phase 3 interventional study of Numeta G13%E and Compounded Parenteral Nutrition (cPN) solution in Malnutrition, Infant and Enteral Feeding Intolerance, sponsored by Baxter Healthcare Corporation. Withdrawn. Open to participants aged 0 Hours to 24 Hours, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by Baxter Healthcare Corporation · Phase 3, Interventional, and Supportive care
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.
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
Browse Malnutrition studies →Baxter Healthcare Corporation is the lead sponsor of 78 studies on the registry; 1 is open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Dose selected and dosing schedule are as deemed appropriate by the ordering attending physician in conjunction with the Investigator.
Will be administered as institutional SOC procedure for the hospital.
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.
Time frame: Baseline (first 24 hours of life) and Day 14
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)
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Week 1, Week 2, Week 3, Week 4
Age (hours) when minimal weight is documented
Measurement=hours.
Time frame: Day 1
Maximum weight loss (%) from birth weight
Measurement=percentage (%).
Time frame: 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.
Time frame: 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.
Time frame: 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).
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
Standard deviation score (SDS or z-score).
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
Standard deviation score (SDS or z-score).
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
Measurement=g/kg/day.
Time frame: Day 7, Day 14, Day 21, Day 28
Weekly gain in Length (cm/week) at Day 7, 14, 21 and 28
Measurement=cm/week.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Baseline up to Week 40
Gain in Weight (g/kg/week) from Baseline to End of study
Measurement=g/kg/week
Time frame: Baseline up to Week 40
Gain in Length (cm/week) from Baseline to End of study
Measurement=cm/week.
Time frame: Baseline up to Week 40
Gain in Head Circumference (cm/week) from Baseline to End of study
Measurement=cm/week.
Time frame: 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
Time frame: 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)
Time frame: Week 1 up to Week 40
Adverse Events of special interest (AESIs)
Time frame: Week 1 up to Week 40
No study locations are listed for this record.
This study is withdrawn, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Baxter Healthcare Corporation