Pedismof Preterm (Three-Chamber Parenteral Nutrition for Preterm Infants)
Combined amino acids, glucose, and SMOF lipid emulsion in a ready-to-use three-chamber bag
Pedismof Preterm is a sterile three-chamber parenteral nutrition bag specifically designed for intravenous feeding of premature newborn infants. Each bag contains three separate chambers holding an amino acid solution with electrolytes, a glucose solution with calcium, and a SMOF lipid emulsion (soybean oil, medium-chain triglycerides, olive oil, and fish oil). The chambers are mixed immediately before infusion to provide a complete, balanced parenteral nutrition admixture when oral or enteral feeding is not possible or is insufficient. Pedismof Preterm is only available by prescription and must be administered under specialist neonatal supervision.
Quick Facts
Key Takeaways
- Pedismof Preterm delivers complete parenteral nutrition for premature infants from a single three-chamber bag containing amino acids with electrolytes, glucose with calcium, and a SMOF multi-oil lipid emulsion.
- The SMOF lipid component (soybean oil, medium-chain triglycerides, olive oil, and fish oil) provides a balanced fatty acid profile with omega-3 long-chain polyunsaturated fatty acids (EPA and DHA) important for neurodevelopment in preterm infants.
- It is contraindicated in infants with hypersensitivity to egg, fish, soy, or peanut protein, severe hyperlipidemia, severe liver failure, or any uncorrected metabolic disorder.
- Due to the high osmolarity of the admixed solution, central venous administration is generally preferred; peripheral infusion is only possible when the composition is adapted accordingly.
- Continuous monitoring of triglycerides, blood glucose, electrolytes, acid-base balance, liver function, and growth is mandatory throughout neonatal parenteral nutrition therapy.
What Is Pedismof Preterm and What Is It Used For?
Pedismof Preterm belongs to the pharmaceutical category of combined parenteral nutrition products (ATC code B05BA10). The bag contains three physically separated chambers that are mixed by the clinician immediately before use by breaking the non-permanent peel seals. After mixing, the bag delivers a homogeneous nutritional admixture comprising protein (as a pediatric amino acid profile enriched with taurine), carbohydrate (as glucose monohydrate), fat (as the SMOF multi-oil lipid emulsion), and a physiologically adapted set of electrolytes, including calcium, magnesium, sodium, potassium, chloride, acetate, and organic phosphate.
The composition is tailored to the metabolic characteristics and growth requirements of preterm newborns, a population with very high nutrient demands relative to body weight and with incompletely developed metabolic, hepatic, and renal pathways. Unlike formulations intended for older children or adults, Pedismof Preterm provides a comparatively lower glucose concentration to reduce the risk of hyperglycemia in the first days of life and a specific amino acid profile with higher amounts of cysteine and taurine, which are considered conditionally essential in premature infants because endogenous synthesis from methionine is immature at birth.
The SMOF lipid component is the distinguishing feature of the product. SMOF stands for Soybean oil, Medium-chain triglycerides, Olive oil, and Fish oil. This balanced blend was developed to address several concerns associated with pure soybean oil lipid emulsions, including an elevated omega-6 to omega-3 fatty acid ratio, a high content of phytosterols that may contribute to intestinal failure-associated liver disease, and relatively low vitamin E content. The fish oil fraction supplies eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which are critical for brain growth and retinal maturation during the last trimester of pregnancy and the first weeks after preterm birth.
Clinically, Pedismof Preterm is indicated when oral or enteral feeding is impossible, insufficient, or contraindicated. This includes very-low-birth-weight and extremely-low-birth-weight infants in the first days of life, preterm babies with immature or compromised gastrointestinal tract, infants recovering from surgical conditions such as gastroschisis, omphalocele, intestinal atresia, or necrotizing enterocolitis, and neonates who cannot tolerate enteral feedings during critical illness. Pedismof Preterm is typically used as part of a combined strategy with minimal enteral feeding whenever feasible, in line with modern neonatal care practice.
International guidelines from the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN), the European Society for Clinical Nutrition and Metabolism (ESPEN), the European Society of Paediatric Research (ESPR), and the Chinese Society of Parenteral and Enteral Nutrition (CSPEN) recommend that parenteral nutrition in preterm infants should start as early as possible after birth and should provide all three macronutrients simultaneously. Ready-to-use three-chamber bags such as Pedismof Preterm simplify this early initiation, reduce handling and compounding errors, and minimize the risk of microbial contamination compared with individually compounded solutions.
What Should You Know Before Pedismof Preterm Is Used?
Because Pedismof Preterm is administered intravenously to one of the most vulnerable patient populations, its use requires careful clinical assessment, a suitable vascular access, and an intensive monitoring strategy. Parents and caregivers should be aware that, although the product is nutritionally comprehensive, it can never fully replicate the complexity of breast milk or enteral feeding. Whenever the infant's clinical condition allows, parenteral nutrition is combined with minimal enteral feeding (trophic feeds) to support gut maturation and minimize parenteral nutrition-associated liver disease.
Contraindications
Pedismof Preterm must not be used in the presence of any of the following conditions:
- Hypersensitivity to fish, egg, soy, or peanut protein or to any of the excipients. The SMOF lipid emulsion contains refined fish oil, refined soybean oil, and egg phospholipids as an emulsifier.
- Severe hyperlipidemia or severely impaired lipid clearance.
- Severe liver failure or hepatic decompensation.
- Severe blood coagulation disorders.
- Congenital errors of amino acid metabolism that are inconsistent with the amino acid profile of the product.
- Severe renal failure without access to hemofiltration or dialysis.
- Acute shock or hemodynamic instability before initial stabilization.
- Hyperglycemia requiring insulin doses above usual neonatal ranges.
- Pathologically increased serum levels of any included electrolyte.
- General contraindications to infusion therapy, including acute pulmonary edema, hyperhydration, decompensated heart failure, and hypotonic dehydration.
- Hemophagocytic syndrome.
- Unstable conditions such as severe post-traumatic states, uncompensated diabetic coma, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis, and hypotonic dehydration.
- Use in preterm newborns of less than 28 weeks of gestational age.
These contraindications are absolute. Even traces of allergens such as egg or fish protein may trigger severe hypersensitivity reactions in sensitized infants, although sensitization is rare at this age. The treating physician must take a thorough family allergy history and document the decision to initiate Pedismof Preterm.
Warnings and Precautions
Pedismof Preterm must be infused exclusively by trained neonatal staff in an environment where intensive monitoring and emergency interventions are available. The infusion should be started slowly and advanced gradually according to protocol, with the infusion rate adjusted to the individual infant's tolerance and the total fluid balance of the day.
Fluid overload, electrolyte disturbances, and hyperglycemia are the most frequent acute complications of neonatal parenteral nutrition. Serum sodium, potassium, magnesium, calcium, phosphate, chloride, glucose, triglycerides, urea, and acid-base status must be checked at baseline and at least daily during the first days of therapy, and more often if clinically indicated. Growth parameters (weight, length, and head circumference) should be measured at regular intervals.
Liver function tests (including transaminases, bilirubin, gamma-glutamyl transferase, and alkaline phosphatase) must be monitored. Parenteral nutrition-associated cholestasis and intestinal failure-associated liver disease remain a concern in long-term treatment; the SMOF lipid composition has been shown in randomized clinical trials to reduce the risk of cholestasis compared with pure soybean oil emulsions, but the risk is not eliminated. If cholestasis develops, the clinical team will reassess the lipid dose, rule out sepsis, and encourage enteral feeding advancement whenever feasible.
The admixed Pedismof Preterm solution, as well as the infusion tubing and any co-infused syringes containing vitamins, must be protected from ambient light and particularly from phototherapy light. Light exposure generates hydroperoxides and other reactive species, especially after the addition of vitamins and trace elements, which can adversely affect clinical outcomes in preterm infants whose antioxidant defenses are immature. Opaque infusion sets and bag covers should be used throughout the infusion.
Because the admixed solution has a high osmolarity, central venous administration is generally preferred. Peripheral administration is only acceptable when the admixture is appropriately diluted or when the product is formulated for peripheral use; otherwise, thrombophlebitis and extravasation injury may occur. Infusion sites must be inspected regularly for signs of redness, swelling, tenderness, or skin breakdown.
Sepsis and catheter-related bloodstream infections are a leading cause of morbidity in preterm infants receiving parenteral nutrition. Strict aseptic technique during central line insertion, line care, and bag handling is mandatory. Use of closed systems, dedicated ports for parenteral nutrition, and protocolized line care bundles reduces infection rates.
- Daily: blood glucose, electrolytes (Na, K, Cl, Ca, Mg, phosphate), fluid balance
- Daily to several times weekly: triglycerides
- At least twice weekly: acid-base status, urea, creatinine
- Weekly: liver function, alkaline phosphatase, gamma-GT, bilirubin
- Weekly: complete blood count, coagulation
- Continuous: temperature, heart rate, respiration, oxygen saturation
- At regular intervals: growth parameters and length/head circumference
Pregnancy and Breastfeeding
Pedismof Preterm is used exclusively in preterm newborn infants. Pregnancy and breastfeeding are therefore not directly applicable to this population. When parenteral nutrition is required in a pregnant or breastfeeding woman for unrelated reasons, a different product formulated for adults must be chosen by the treating physician, who will weigh the risks and benefits for mother and child.
Effects on Ability to Drive and Use Machines
Not applicable. Pedismof Preterm is administered to newborn infants in a neonatal intensive care setting.
How Does Pedismof Preterm Interact with Other Drugs?
Because Pedismof Preterm is a complex emulsion containing amino acids, glucose, electrolytes, and lipids, many physicochemical and pharmacological interactions are possible. As a general rule, no additional medication should be administered through the same line as the parenteral nutrition admixture unless compatibility has been verified by the hospital pharmacy. A dedicated lumen of the central venous catheter is strongly preferred for parenteral nutrition.
Major Physicochemical Interactions
Ceftriaxone, when infused simultaneously with calcium-containing solutions such as Pedismof Preterm, can form calcium ceftriaxone precipitates that have been associated with fatal pulmonary and renal events in neonates. Ceftriaxone must not be administered through the same intravenous line as Pedismof Preterm, and in neonates, co-administration of ceftriaxone and calcium-containing IV solutions is generally contraindicated regardless of the line used, unless separated by a defined flushing procedure and adequate time.
Heparin in pharmacological doses may destabilize lipid emulsions and alter lipid clearance by lipoprotein lipase. While small prophylactic heparin doses added to central lines are widely used, therapeutic heparin infusion should not be mixed directly with Pedismof Preterm.
Certain intravenous antibiotics, antifungals, and vasoactive drugs are physically incompatible with parenteral nutrition admixtures. Neonatal intensive care units typically maintain compatibility charts listing which medications may be Y-site co-administered with their standard parenteral nutrition bags. These charts must be consulted before any co-infusion.
Pharmacological Interactions
Insulin requirements may change during Pedismof Preterm infusion because the glucose and lipid loads affect overall energy substrate delivery. Insulin infusions used to manage neonatal hyperglycemia should be titrated against blood glucose, and the rate may need to be adjusted when the parenteral nutrition infusion is started, changed, or interrupted.
The natural oils in the lipid emulsion contain small amounts of vitamin K. These quantities are not normally sufficient to interfere with coumarin-type anticoagulants (e.g., warfarin). However, if such medications are ever used in an older pediatric patient receiving SMOF-based parenteral nutrition, more frequent monitoring of the international normalized ratio (INR) is prudent.
Cyclosporine, sirolimus, and other lipophilic drugs may have altered absorption into lipid emulsions. If such medications are used in infants receiving Pedismof Preterm (a rare but possible situation), closer therapeutic drug monitoring is warranted.
| Interacting Substance | Type | Effect | Clinical Action |
|---|---|---|---|
| Ceftriaxone | Major physicochemical | Precipitation of calcium-ceftriaxone crystals (risk of fatal events in neonates) | Do not co-administer in neonates; use separate lines with flushing or avoid combination |
| Heparin (therapeutic doses) | Physicochemical | Destabilization of lipid emulsion; altered lipoprotein lipase activity | Do not mix in same line; monitor aPTT and triglycerides |
| Insulin | Pharmacological | Altered glucose and lipid handling; risk of hypoglycemia or hyperglycemia | Continuous glucose monitoring; titrate insulin to infusion rate changes |
| Coumarin anticoagulants (warfarin) | Minor pharmacological | Small amounts of vitamin K in lipid emulsion may reduce anticoagulant effect | Monitor INR more frequently (rarely relevant in neonates) |
| Cyclosporine, tacrolimus, sirolimus | Minor pharmacological | Lipophilic drug distribution may change in presence of lipid emulsion | Intensify therapeutic drug monitoring if used |
| Calcium-containing solutions (in same line) | Physicochemical | Risk of precipitation; destabilization of emulsion | Avoid mixing; use dedicated line for PN |
Healthcare professionals must inform the hospital pharmacy of any concomitant medication planned during parenteral nutrition. When additives such as trace elements, vitamins, or specific electrolytes must be added to Pedismof Preterm, this must only be done by trained personnel under strictly aseptic conditions, using products with documented compatibility and stability, and infused immediately after preparation.
What Is the Correct Dosage of Pedismof Preterm?
The dose of Pedismof Preterm must be determined individually by the neonatologist, based on the infant's gestational age, postnatal age, weight, clinical condition, metabolic tolerance, and ongoing enteral intake. Parenteral nutrition in preterm infants is progressive: target macronutrient doses are approached over several days, starting on the first day of life, and reduced again as enteral feeding advances. The reference framework below is consistent with the 2018 ESPGHAN/ESPEN/ESPR/CSPEN guidelines and current neonatal practice; the concrete daily doses remain the responsibility of the treating physician.
Amino Acids
Target Protein Intake
In very-low-birth-weight and extremely-low-birth-weight preterm infants, parenteral amino acid delivery should start on day one of life at approximately 1.5–2 g/kg/day, and increase to 2.5–3.5 g/kg/day (up to 4 g/kg/day in the most immature neonates) within the first postnatal days. Protein delivery below 1.5 g/kg/day on day one is associated with increased catabolism and poor growth. Intake above 4 g/kg/day does not provide additional benefit and may cause azotemia and acidosis.
Glucose
Carbohydrate Intake
Glucose is the main energy substrate. Initial glucose infusion rates are typically 4–8 mg/kg/min (about 6–12 g/kg/day) and advance by 1–2 mg/kg/min per day as tolerated, up to a maximum of approximately 12 mg/kg/min (17 g/kg/day). Intensive blood glucose monitoring is required, and the glucose infusion rate is reduced if hyperglycemia (>10 mmol/L or ~180 mg/dL) persists or if insulin is started.
Lipids (SMOF)
Lipid Intake
Intravenous lipids should start on day one of life at approximately 1–2 g/kg/day, and advance to a target of 3–4 g/kg/day within a few days. Starting doses below 0.5–1 g/kg/day are insufficient to prevent essential fatty acid deficiency in preterm neonates, which can occur within days. Doses above 4 g/kg/day are not recommended in this population. Triglyceride levels should be monitored; if plasma triglycerides exceed approximately 2.8–3.4 mmol/L (250–300 mg/dL), the lipid infusion rate should be reduced.
Infusion Rate
Infusion Rate
Pedismof Preterm is administered as a continuous infusion over 24 hours. Rapid or cyclic infusion is not appropriate in preterm infants because of the risk of fat overload and metabolic instability. The infusion pump must deliver the rate precisely and must have occlusion and air-in-line alarms. After any change in the infusion rate, nutritional and glycemic tolerance should be verified.
Dosage Summary
| Macronutrient | Starting Dose (Day 1) | Target Dose | Key Monitoring |
|---|---|---|---|
| Amino acids | 1.5–2 g/kg/day | 2.5–3.5 g/kg/day (up to 4) | Urea, acid-base, growth |
| Glucose | 4–8 mg/kg/min | Up to 12 mg/kg/min | Blood glucose, urinary glucose |
| SMOF lipids | 1–2 g/kg/day | 3–4 g/kg/day | Plasma triglycerides |
| Total fluid | 60–80 mL/kg/day | 140–160 mL/kg/day (adjusted) | Weight, urine output, electrolytes |
Route of Administration
Because of the high osmolarity of the admixed Pedismof Preterm solution, infusion through a central venous catheter (for example, an umbilical venous catheter, a peripherally inserted central catheter, or a tunneled central line) is recommended. Peripheral administration may lead to thrombophlebitis and should be reserved for short-term use with specifically adapted, lower-osmolarity preparations. The tip of a central catheter should not be placed in the heart chambers or in a small peripheral vein, and correct catheter position must be verified by imaging before starting infusion.
Pedismof Preterm is used as part of total parenteral nutrition. Additional trace elements, water- and fat-soluble vitamins must be prescribed according to neonatal requirements and, if compatible, added to the bag or co-administered, because the product itself does not contain vitamins or trace elements.
Overdose
An overdose of Pedismof Preterm in preterm infants can result in fluid overload, electrolyte disturbances, hyperglycemia, glucosuria, hyperosmolar syndrome, metabolic acidosis, hyperlipidemia, and fat overload syndrome. In neonates and infants, overdose or excessively rapid infusion of lipid emulsions can cause respiratory distress, hypoxia, and metabolic acidosis that typically reverse after discontinuation.
Fat overload syndrome is characterized by a sudden deterioration of the infant's clinical condition with hyperlipidemia, fever, fatty infiltration of the liver, hepatomegaly, anemia, leukopenia, thrombocytopenia, coagulopathy, and, in severe cases, coma. If overdose or fat overload syndrome is suspected, the infusion must be stopped immediately. Further management includes supportive intensive care, correction of fluid and electrolyte disturbances, management of hyperglycemia, and careful reintroduction of reduced doses once the infant is stable.
Missed Dose
Since Pedismof Preterm is administered as a continuous infusion in a neonatal intensive care unit, a missed dose is uncommon. If an infusion is interrupted for any reason, the clinical team will assess fluid and energy balance, check blood glucose, and resume the infusion at the prescribed rate; a missed period is not compensated by doubling the rate afterward, as this increases the risk of hyperglycemia and fat overload.
What Are the Side Effects of Pedismof Preterm?
Like all medicines used in intensive care, Pedismof Preterm can cause side effects. In the neonatal population these are sometimes difficult to separate from the effects of prematurity itself and of the underlying illness. Preterm infants are particularly susceptible to metabolic side effects because their enzymatic pathways, antioxidant systems, and organ reserves are incompletely developed.
The infusion must be discontinued immediately if the baby develops any unusual signs or symptoms during administration, including fever, chills, a drop or spike in blood pressure, tachycardia or bradycardia, sudden desaturation, respiratory distress, vomiting, skin rash, or an abrupt change in alertness or tone. Any such event must be reported, evaluated, and documented by the medical team.
Common Side Effects
Affects 1 to 10 in every 100 patients
- Hyperglycemia (elevated blood glucose)
- Elevated plasma triglycerides
- Electrolyte disturbances (hyperkalemia, hypokalemia, hypophosphatemia)
- Transient elevation of liver enzymes (AST, ALT, gamma-GT)
- Hypotension or transient changes in blood pressure
- Tachycardia
Uncommon Side Effects
Affects 1 to 10 in every 1,000 patients
- Cholestasis (elevated direct bilirubin) and parenteral nutrition-associated liver disease
- Thrombophlebitis at the infusion site
- Headache (in older children)
- Abdominal pain, nausea, vomiting (in older children)
- Leukopenia or thrombocytopenia
- Hepatic steatosis (fatty liver)
- Skin rash, itching, flushing
Rare Side Effects
Affects fewer than 1 in every 1,000 patients
- Severe hypersensitivity reactions (urticaria, angioedema, anaphylactic reaction)
- Cyanosis, dyspnea, apnea
- Priapism (very rare, reported for lipid emulsions in general)
- Severe hepatic dysfunction
Frequency Unknown
Cannot be estimated from available data
- Fat overload syndrome (sudden deterioration with hyperlipidemia, fever, hepatomegaly, coagulopathy)
- Catheter-related bloodstream infection, sepsis
- Metabolic acidosis
- Disturbance of osmolarity balance, hyperosmolar syndrome
- Refeeding syndrome in malnourished infants
- Precipitation with incompatible medications (e.g., calcium-ceftriaxone)
Fat Overload Syndrome
Fat overload syndrome is a rare but potentially severe complication of intravenous lipid emulsions. In preterm infants, it may result from doses above the tolerated lipid load, from an infusion rate exceeding the plasma clearance of triglycerides, or from a combination of parenteral lipids with concomitant illness (such as severe infection) that transiently impairs lipoprotein lipase activity. Signs include a rapid rise in plasma triglycerides, persistent fever, a sudden drop in platelet count, hepatomegaly, cholestasis, and, in severe cases, bleeding disorders and respiratory compromise. The infusion must be stopped immediately, and the treatment is supportive, with gradual reintroduction only after full recovery of lipid clearance.
Parenteral Nutrition-Associated Liver Disease
Intestinal failure-associated and parenteral nutrition-associated liver disease is a well-recognized complication of long-term parenteral nutrition in preterm infants. It ranges from isolated cholestasis to biliary fibrosis and, in the most severe cases, cirrhosis. Risk factors include extreme prematurity, delayed initiation of enteral feedings, recurrent sepsis, and prolonged exposure to pure soybean oil-based lipid emulsions with high phytosterol content. SMOF-based lipid emulsions, including the one in Pedismof Preterm, have been shown in randomized studies and meta-analyses to reduce the incidence and severity of cholestasis compared with pure soybean oil lipids, particularly when combined with early enteral feeding.
All suspected adverse reactions associated with Pedismof Preterm should be reported to the national pharmacovigilance authority (for example, the FDA MedWatch program in the United States, or the European Medicines Agency and national agencies in the European Union). Reporting helps to continuously monitor the safety profile of neonatal parenteral nutrition products.
How Should Pedismof Preterm Be Stored?
Correct storage is essential to preserve the sterility, stability, and physical integrity of the three-chamber bag. Incorrect storage can result in phase separation of the lipid emulsion, crystallization of salts, Maillard browning of amino acids with glucose, or loss of sterility, any of which is unsafe for a preterm infant.
- Temperature: Store below 25°C. Do not freeze. A frozen bag, even if fully thawed again, must not be used because the emulsion structure can be irreversibly damaged and ice crystals may have breached the inner seals.
- Light protection: Keep the bag in its original outer protective packaging until immediately before use. Protect the activated bag and the administration set from light during infusion, especially in the presence of phototherapy.
- Packaging integrity: Do not use if the outer pouch is perforated, if the inner bag is damaged, or if the peel seals between chambers are already broken. In such cases, the product has lost its sterility or stability and must be discarded.
- Visual inspection: Before activation, the amino acid and glucose chambers should appear as clear solutions, and the lipid chamber as a homogeneous, milky-white emulsion. After mixing, the combined admixture should be a homogeneous, milky-white emulsion without visible phase separation, oil droplets on the surface, or particulates.
- Expiration date: Do not use beyond the expiration date printed on the bag. The expiration date refers to the last day of the indicated month.
- After activation: Once the peel seals have been broken and the chambers mixed, the admixture should be used immediately. If, exceptionally, use is delayed, the bag must be kept under controlled conditions as documented by the hospital pharmacy, and any unused portion must be discarded no later than the storage period permitted by the product labeling.
- Waste handling: Unused Pedismof Preterm, as well as any contaminated materials, must be disposed of according to local pharmaceutical waste regulations.
Partially used Pedismof Preterm bags must not be saved and reconnected for later use, because of the risks of microbial contamination and air embolism from residual air in the primary bag. Each new infusion requires a new sterile bag, new administration set, and freshly verified additives.
What Does Pedismof Preterm Contain?
Understanding the precise composition of Pedismof Preterm is important for both physicochemical compatibility decisions and clinical decisions regarding allergies, electrolyte balance, and macronutrient prescription. The exact per-liter amounts may vary slightly between product variants and formulations; the table below reflects typical values for a preterm-adapted three-chamber bag.
Active Components
| Component | Typical Amount |
|---|---|
| Amino acids | ~25 g/L |
| Nitrogen | ~3.5 g/L |
| Glucose (as monohydrate) | ~120 g/L |
| SMOF lipid emulsion | ~37.5 g/L |
| Total energy | ~900–1000 kcal/L |
| Sodium | ~20 mmol/L |
| Potassium | ~17 mmol/L |
| Magnesium | ~1.5 mmol/L |
| Calcium | ~4 mmol/L |
| Phosphate (organic) | ~7.5 mmol/L |
| Osmolarity (admixed) | ~1500 mOsm/L |
| pH | ~5.5 |
Amino Acid Profile
The amino acid profile is adapted to the unique needs of preterm infants and includes essential amino acids (isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine, histidine), non-essential amino acids (alanine, arginine, aspartic acid, glutamic acid, glycine, proline, serine), and the conditionally essential amino acids cysteine/cystine, tyrosine, and taurine. Taurine is included because it is crucial for bile acid conjugation and retinal development in preterm infants, who have limited endogenous synthesis.
SMOF Lipid Composition
The lipid chamber contains the multi-oil SMOF emulsion. The typical composition of the fat source is:
- Refined soybean oil: ~30%. Provides essential polyunsaturated fatty acids (linoleic and alpha-linolenic acid).
- Medium-chain triglycerides (MCT): ~30%. Rapidly oxidized source of energy that is independent of the carnitine shuttle, with reduced immunomodulatory effects.
- Refined olive oil: ~25%. Provides monounsaturated oleic acid and limits the total load of polyunsaturated fatty acids.
- Refined fish oil: ~15%. Supplies long-chain omega-3 polyunsaturated fatty acids (EPA and DHA) essential for neurodevelopment.
The emulsion also contains natural alpha-tocopherol (vitamin E) as an endogenous antioxidant. The omega-6 to omega-3 fatty acid ratio is substantially lower than in pure soybean oil emulsions, which is considered beneficial for the inflammatory and hepatic profile of the preterm infant.
Excipients
- Glycerol: Isotonicity agent in the lipid chamber.
- Purified egg phospholipids: Emulsifier for the lipid phase. Patients with documented egg hypersensitivity must not receive the product.
- Sodium oleate: Co-emulsifier contributing to emulsion stability.
- Sodium hydroxide and/or hydrochloric acid: Used for pH adjustment to maintain a physiologically compatible pH.
- Water for injections: The aqueous phase of the admixture, meeting pharmacopeial standards for sterile water.
Appearance and Packaging
Pedismof Preterm is supplied in a multi-layer plastic three-chamber bag with non-permanent peel seals separating the amino acid/electrolyte, glucose/calcium, and lipid emulsion chambers. The bag is placed inside an outer protective pouch with an oxygen-absorbing sachet to prevent degradation during shelf life. After removing the outer pouch, the inner bag is gently squeezed to break the peel seals, and the three chambers are mixed to yield a homogeneous milky-white emulsion suitable for infusion. The bag is intended for single use only.
How Is Pedismof Preterm Prepared and Administered?
The following instructions are intended for neonatal healthcare professionals. Proper handling is critical to maintain sterility, stability, and safe administration.
Preparation Steps
- Check prescription: Verify the prescription, patient identity, and planned dose against the neonatal parenteral nutrition order.
- Inspect: Remove the outer pouch and oxygen absorber. Verify that the bag is undamaged, that the peel seals between chambers are intact, and that the solutions and emulsion appear clear and homogeneous respectively.
- Warm: Bring the bag to approximately room temperature before activation. Do not heat with direct heat sources.
- Activate: Place the bag on a clean, flat surface. Roll the bag from the top toward the administration port to break the peel seals between the chambers. Mix thoroughly by gentle inversion so that the contents become a homogeneous, milky-white emulsion.
- Additives: Under strictly aseptic conditions, add any prescribed and documented-compatible additives (vitamins, trace elements, extra electrolytes) through the additive port. Mix again gently.
- Inspection after mixing: Re-inspect the bag to confirm a uniform appearance with no oil droplets, phase separation, color change, or particles.
- Spike and hang: Remove the plastic cap from the administration port and firmly insert the spike of a light-protected administration set. Purge the line.
- Label and start: Apply the patient label with bag composition, additives, rate, and start time. Start the infusion via a calibrated pump with appropriate alarms.
Important Administration Notes
- The activated bag must be infused immediately, or stored according to the in-house validated protocol and used within the documented period.
- Bags must never be connected in series because of the risk of air embolism from residual air in the primary bag.
- No additives are permitted other than those with documented compatibility. Uncertain combinations must be referred to the hospital pharmacy.
- The infusion set and bag must be protected from light in preterm infants, including during phototherapy.
- A central catheter should be used whenever possible; correct catheter tip position must be verified by imaging.
- All unused material must be disposed of according to local regulations for pharmaceutical waste.
Frequently Asked Questions About Pedismof Preterm
Pedismof Preterm is a complete parenteral nutrition product specifically designed for premature newborn infants. It is used when oral or enteral feeding is not possible or is insufficient, for example in the first days of life of very-low-birth-weight babies, during recovery from major abdominal surgery, in infants with necrotizing enterocolitis, and in preterm neonates with compromised gut function. Pedismof Preterm supplies amino acids with electrolytes, glucose with calcium, and a SMOF multi-oil lipid emulsion from a single three-chamber bag, enabling balanced and timely parenteral nutrition in neonatal intensive care.
Pedismof Preterm has been developed specifically for preterm infants and is used widely in neonatal intensive care. When prescribed and monitored according to modern protocols and international guidelines (ESPGHAN/ESPEN/ESPR/CSPEN 2018), it is considered safe in this population. Like all intravenous nutrition, it carries risks including hyperglycemia, elevated triglycerides, cholestasis, and catheter-related infections; these are managed by careful dose titration, strict asepsis, light protection, and comprehensive laboratory monitoring. Parents should discuss specific concerns with the neonatology team caring for their baby.
SMOF is an acronym for the four oils used in the lipid emulsion: Soybean oil, Medium-chain triglycerides, Olive oil, and Fish oil. This multi-oil composition provides a balanced profile of essential polyunsaturated fatty acids, rapidly metabolized medium-chain triglycerides, monounsaturated oleic acid, and long-chain omega-3 fatty acids (EPA and DHA). Compared with pure soybean oil lipid emulsions, SMOF emulsions have a lower omega-6 to omega-3 ratio, a lower phytosterol load, and more natural vitamin E, which are considered beneficial for the hepatic and inflammatory profile of preterm infants.
Parenteral nutrition admixtures, and particularly those containing lipids and vitamins, generate hydroperoxides and other reactive species when exposed to ambient light or phototherapy. Preterm infants have immature antioxidant systems, so these oxidation products can contribute to inflammation, lung injury, and liver complications. Light protection of the bag and infusion tubing has been shown in clinical trials to reduce oxidative stress and to improve clinical outcomes in this population, and it is therefore recommended throughout the infusion of Pedismof Preterm.
The duration depends entirely on the baby's clinical course. Some preterm infants need parenteral nutrition for only a few days, until they can tolerate enteral feeds. Others with very low birth weight or severe intestinal pathology may need weeks of parenteral nutrition before enteral feeds can fully replace it. Throughout therapy, the team performs continuous monitoring of growth, electrolytes, glucose, triglycerides, liver function, and signs of cholestasis. Enteral feeds are advanced as early and as quickly as the baby tolerates, because early enteral nutrition helps to protect the liver and the gut from complications of prolonged parenteral nutrition.
The fully admixed Pedismof Preterm solution has a high osmolarity, which means that central venous administration (through an umbilical venous catheter, a peripherally inserted central catheter, or a tunneled central line) is generally preferred. Peripheral administration is only acceptable for lower-osmolarity formulations specifically designed for this route, or for limited periods before central access can be established. Using a small peripheral vein for high-osmolarity parenteral nutrition increases the risk of thrombophlebitis and extravasation injury in the fragile skin of a preterm infant.
Monitoring is the cornerstone of safe neonatal parenteral nutrition. Blood glucose and electrolytes are typically checked at least daily in the first days of life, together with fluid balance and body weight. Triglycerides are monitored when lipid doses are advanced. Liver function tests, coagulation, and complete blood counts are measured weekly, and more frequently if clinical concerns arise. Catheter sites are inspected regularly for infection or extravasation. Growth parameters, including weight, length, and head circumference, are measured and plotted on preterm growth charts. The specific monitoring plan is individualized by the neonatal team.
References
This article is based on the following peer-reviewed sources and international medical guidelines:
- Mihatsch WA, Braegger C, Bronsky J, et al. ESPGHAN/ESPEN/ESPR/CSPEN guidelines on pediatric parenteral nutrition. Clinical Nutrition. 2018;37(6 Pt B):2303-2305. doi:10.1016/j.clnu.2018.05.029
- Lapillonne A, Fidler Mis N, Goulet O, et al. ESPGHAN/ESPEN/ESPR/CSPEN guidelines on pediatric parenteral nutrition: Lipids. Clinical Nutrition. 2018;37(6 Pt B):2324-2336. doi:10.1016/j.clnu.2018.06.946
- Mesotten D, Joosten K, van Kempen A, Verbruggen S. ESPGHAN/ESPEN/ESPR/CSPEN guidelines on pediatric parenteral nutrition: Carbohydrates. Clinical Nutrition. 2018;37(6 Pt B):2337-2343. doi:10.1016/j.clnu.2018.06.947
- van Goudoever JB, Carnielli V, Darmaun D, et al. ESPGHAN/ESPEN/ESPR/CSPEN guidelines on pediatric parenteral nutrition: Amino acids. Clinical Nutrition. 2018;37(6 Pt B):2315-2323. doi:10.1016/j.clnu.2018.06.945
- Hartman C, Shamir R, Simchowitz V, et al. ESPGHAN/ESPEN/ESPR/CSPEN guidelines on pediatric parenteral nutrition: Complications. Clinical Nutrition. 2018;37(6 Pt B):2418-2429. doi:10.1016/j.clnu.2018.06.956
- European Medicines Agency (EMA). Guidelines and product information on parenteral nutrition for preterm neonates. EMA. Available at: www.ema.europa.eu
- Goulet O, Antebi H, Wolf C, et al. A new intravenous fat emulsion containing soybean oil, medium-chain triglycerides, olive oil, and fish oil: a single-center, double-blind randomized study on efficacy and safety in pediatric patients receiving home parenteral nutrition. Journal of Parenteral and Enteral Nutrition. 2010;34(5):485-495. doi:10.1177/0148607110363614
- Rayyan M, Devlieger H, Jochum F, Allegaert K. Short-term use of parenteral nutrition with a lipid emulsion containing a mixture of soybean oil, olive oil, medium-chain triglycerides, and fish oil: a randomized double-blind study in preterm infants. Journal of Parenteral and Enteral Nutrition. 2012;36(1 Suppl):81S-94S. doi:10.1177/0148607111424411
- Repa A, Binder C, Thanhaeuser M, et al. A mixed lipid emulsion for prevention of parenteral nutrition-associated cholestasis in extremely low birth weight infants: a randomized clinical trial. The Journal of Pediatrics. 2018;194:87-93.e1. doi:10.1016/j.jpeds.2017.11.012
- Kapoor V, Malviya MN, Soll R. Lipid emulsions for parenterally fed preterm infants. Cochrane Database of Systematic Reviews. 2019;6:CD013163. doi:10.1002/14651858.CD013163.pub2
- World Health Organization (WHO). Optimal feeding of low-birth-weight infants in low- and middle-income countries. WHO Guidelines. Available at: www.who.int
- U.S. Food and Drug Administration (FDA). Information on intravenous lipid emulsions. FDA. Available at: www.fda.gov
- British National Formulary for Children (BNFC). Parenteral nutrition. BNFC. Current version.
- Fresenius Kabi. Pedismof Preterm — Summary of Product Characteristics. Current version.
About This Article
This article was prepared by the iMedic Medical Editorial Team, a group of licensed specialist physicians with expertise in neonatology, clinical pharmacology, and pediatric nutrition. All content has been reviewed against official product information and the current international guidelines of ESPGHAN, ESPEN, ESPR, CSPEN, the WHO, the EMA, and the FDA.
All pharmaceutical information is verified against official product labeling, peer-reviewed clinical studies, and current international guidelines. Our editorial process follows the GRADE evidence framework to ensure the highest quality of medical information.
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