Korea still relies on manual jobs to provide nutrition therapy for preterm infants: experts

The Neonatal Intensive Care Unit (NICU) is a high-intensity clinical setting where life-sustaining treatments occur in real-time. Particularly for preterm infants born before 32 weeks or weighing less than 1,500 grams, immature gastrointestinal function makes enteral feeding difficult.

Consequently, supplying protein and energy via parenteral nutrition (PN) is essential from the earliest days of life. However, experts have expressed concerns that PN therapy is faltering from the outset due to issues, such as healthcare staff shortages, limited pharmacy preparation times, and limitations in emergency response during nights and weekends.

Parenteral Nutrition (PN), primarily used in Neonatal Intensive Care Units (NICUs), is administered through Individualized PN (IPN) tailored to each infant's condition.

However, IPN involves a complex preparation process and is highly labor-intensive, presenting significant constraints during night shifts and weekends.

“In the NICU, a patient's condition can change many times a day, making the frequent preparation of new IPN a significant burden,” said Professor Jo Heui-seung of the Department of Pediatrics at Kangwon National University Hospital at a recent workshop. “Most hospitals have PN prescription deadlines, making it difficult to respond during nights and weekends.”

Professor Lee Jang-hoon of the Department of Pediatrics at Ajou University Hospital also stated, “While NICUs sometimes pre-compound ‘Starter PN’ internally for use after PN prescription deadlines and for emergency responses, it often must be discarded after a certain period, leading to resource waste.”

While IPN offers the advantage of flexible adjustment based on the patient's condition, risks of human error and infection during the compounding process persist. Medication errors in the NICU can lead to more severe harm than in other age groups. According to published international studies, medication errors occur in approximately 25–91 percent of NICU patients. A 2018 study by Johns Hopkins Children's Hospital revealed that prescription or order errors during IPN preparation accounted for about 22 percent of all PN-related errors.

Professor Jeong Ji-eun of the Department of Pediatrics at Daegu Catholic University Medical Center remarked, “While IPN that can be flexibly adjusted according to changes in the patient's condition is ideal, realistically, except for some hospitals, most hospitals find it difficult to provide 24-hour real-time response. Pre-compounded SPN (Standardized Parenteral Nutrition, SPN) can be a more stable choice, as it can reduce errors and infection risks during the manufacturing process.”

Parenteral Nutrition (PN) Compounders, automated devices that precisely compound complex medications like parenteral nutrition solutions (PN) in a sterile environment, are considered key equipment for enhancing compounding efficiency and safety. However, only about 20 hospitals in Korea possess this equipment, meaning most NICUs still rely on manual PN compounding.

Furthermore, while the role of the Nutrition Support Team (NST)—a multidisciplinary team that assesses patient nutritional status and designs/manages optimal treatment—is crucial, NST operations in Korea are limited due to a shortage of specialized personnel.

Given this situation, coupled with the steady rise in preterm birth rates due to aging mothers and increased artificial insemination, the burden of preparation within NICUs and gaps in nutritional therapy are likely to worsen significantly. Consequently, the need for SPN formulations, which reduce dependence on time and personnel and enable immediate response, is growing.

‘Europe has an SPN-oriented system, starting with SPN and transiting to IPN according to conditions’

Professor Lee Ju-young of the Department of Pediatrics at Korea University Anam Hospital, citing the physician’s own NICU experience in Finland, said, “In Finland, it is common to start with SPN and transition to IPN based on the patient's condition. In environments with limited NICU personnel, SPN is significantly more efficient.”

Indeed, major pediatric nutrition societies in Europe and Asia, including ESPGHAN, ESPEN, ESPR, and CSPEN, generally recommend SPN for most patient groups, including preterm infants. Numerous studies indicate that SPN aids long-term growth, as well as brain and lung development, by enabling higher nutrient intake, including protein.

Regarding this, Professor Lee Jang-hoon commented, “Ready-to-use SPN formulations hold greater significance in improving healthcare providers' workflow and reducing pharmacists' dispensing burden than in improving clinical indicators.”

Concerning the potential domestic introduction of ready-to-use SPN products, healthcare providers agreed that while it may be difficult to target the entire patient population, it could be used as a complementary approach for stable patients.

“Customized prescriptions remain necessary for metabolically unstable or very low birth weight (VLBW) infants, but SPN may be appropriate for newborns weighing over 1kg who are relatively stable,” Professor Lee Jang-hoon said. “Korea’s NICU environment, where patient groups with vastly different weights and conditions coexist, a ‘hybrid strategy’ combining SPN and IPN is a realistic approach.”

Professor Jo agreed, saying, “It is rare for a single infant to receive only SPN or only IPN continuously. In most cases, SPN and IPN are used in combination, depending on the infant's condition. Rather than relying solely on one method like breast milk or formula, a flexible approach combining methods as needed is the realistic approach.”

Professor Jung Eui-seok of the Department of Pediatrics and Neonatology at Asan Medical Center said that AMC’s IPN preparation system and protocols are well-established, so the need for SPN introduction is relatively low.

“However, in situations where patient numbers surge, utilizing standardized fluids for relatively stable patients allows for more efficient allocation of medical resources to high-risk patients requiring intensive care,” Jung said. “In this regard, the introduction of SPN has clear advantages.”

He continued, “Currently, in the NICU, pre-prepared Starter PN is often discarded after a certain period, and the volume discarded is not insignificant. SPN, with its long shelf life and stable formulation, is expected to reduce unnecessary waste and enhance the efficiency of pharmaceutical resource utilization.”

Experts also noted that the recent instability in the supply of electrolyte components, such as sodium acetate, has become an obstacle in PN preparation, citing this as a reason for introducing SPN.

“Currently, acetate is only available through the Orphan Drug Center, leading to competition among hospitals to secure it whenever supply becomes available,” Professor Lee Ju-young said. “Using SPN formulations that already contain this component could be a practical solution.”

Meanwhile, the currently available Ready-to-use Standardized Parenteral Nutrition (RTU SPN) product in Korea is Numeta G13E, developed by Baxter. Numeta G13E is a triple-chamber bag SPN product for premature infants weighing 2.5kg or less or with a gestational age of less than 37 weeks. It enables immediate administration upon prescription, maintains sterility, allows room-temperature storage, and can be used immediately in emergency situations.