FDA Approves New Use of Vital Nutrition Infusion for Newborns
Key Takeaways
- FDA approval extends use of lipid injectable emulsion to neonates.
- Approximately 40% of PN patients are under 18 years old.
- Clinical trials show the emulsion does not cause essential fatty acid deficiency.
Did You Know?
Introduction: A New Milestone for Pediatric Nutrition
The U.S. Food and Drug Administration (FDA) has recently extended the approval of lipid injectable emulsion, a vital nutrition infusion, for use in newborns. This move marks a significant step in pediatric healthcare, benefiting preterm and term neonates who rely on intravenous sources of nourishment.
Understanding Lipid Injectable Emulsion
Lipid injectable emulsion is a specially formulated mixture designed by Baxter International to deliver essential calories and fatty acids when regular feeding methods aren't viable. Available for adults since 2019, this emulsion is now accessible to patients of all ages, including infants. This change offers more flexibility and choices for healthcare providers handling critical cases.
Significance for Pediatric Patients
Approximately 40% of patients needing parenteral nutrition (PN) in the United States are under the age of 18. Expanding the label to include neonates means that younger, more vulnerable patients will receive the nutrition they need from a proven source. This increase in the patient demographic showcases the emulsion’s reliability and adaptability.
Composition of Lipid Injectable Emulsion
Compared to other intravenous lipid emulsions (ILEs) available in the U.S., Baxter's lipid injectable emulsion contains 20% soybean oil and 80% olive oil. This unique composition aims at providing balanced nutrition while reducing the risk of essential fatty acid deficiency (EFAD).
Clinical Trials and Findings
In a significant phase 4 study, the lipid injectable emulsion was tested on pediatric patients aged 0 to 17. This study, completed in November 2022, involved 101 participants in a double-blind trial. The study compared Baxter’s emulsion with a standard soybean oil-based emulsion to observe the outcomes related to EFAD.
Study Results
The primary goal was to measure the number of participants who developed EFAD using the Holman Index. The results indicated that neither the test group (receiving lipid injectable emulsion) nor the control group (receiving soybean oil-based emulsion) developed EFAD. This outcome underscores the safety and efficacy of Baxter’s product in pediatric care.
Administration Method
Both emulsions were administered intravenously in a controlled hospital setting over spans ranging from 7 to 90 days. The prescribed flow rate ensured safe and effective delivery, capped at a maximum lipid infusion rate of 0.15 g/kg per hour.
Impact and Future Implications
This FDA approval broadens treatment options in pediatric nutrition, providing clinicians with a versatile product. It indicates a forward stride in ensuring that critical and vulnerable populations receive the nutrition support they need during early developmental stages.
Conclusion
Overall, the expansion of the lipid injectable emulsion label to include neonates and young children represents improvement in pediatric medical care. Parents and medical providers can now take comfort in knowing that there are safe, effective options for children who require parenteral nutrition.
