Ciptomangunkusumo Public Hospital
Jakarta Pusat, DKI Jakarta, 12810, Indonesia
NCT Number: NCT07801040
This study aims to determine the differences in outcomes in groups with protein restriction in parenteral nutrition of critically ill infants, compared with protein regimens according to local guidelines.
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Notify Me72 hour–1 month
All sexes
Interventional
Not applicable
Jakarta Pusat, DKI Jakarta, 12810, Indonesia
Critical illness in neonates can be caused by various causes, including sepsis, major surgery, or other injuries with tissue damage (trauma, hypoxic-ischemia, severe cardio-respiratory disorders, or acute conditions requiring intensive care). Metabolic changes that occur are aimed at survival, but when these processes are disrupted, it can lead to multiorgan dysfunction and even death. The timing of the initiation of nutritional support can significantly influence the nutritional and clinical outcomes of critically ill infants and children. The Pediatric Early versus Late Parenteral Nutrition in Intensive Care Unit (PEPaNIC) study showed higher morbidity rates in critically ill infants and children who received supplemental parenteral nutrition early compared with subjects who had it delayed for 1 week. These short-term outcomes included shorter PICU stays and earlier weaning from mechanical ventilation. ESPGHAN-CoN does not recommend a shift towards withholding parenteral nutrition support for 7 days as part of routine nutritional care. Instead, the current position paper suggests a cautious approach to initiating parenteral nutrition support in critically ill term newborns after 48-72 hours on an individual basis, and suggests that parenteral nutrition support can be delayed until day 8 for term infants with normal nutritional status and a low risk of nutritional deterioration.
The principles of altered nutritional requirements and metabolic changes in critically ill neonates are poorly understood due to limited research. Studies in adults and children indicate significant metabolic changes, including reduced nutrient absorption and an inability to utilize administered nutrients. Protein is mobilized to meet specific amino acid requirements as precursors for gluconeogenesis and acute-phase reactant synthesis in the liver. Energy mobilization through protein and fat catabolism can occur for up to several days, resulting in growth arrest.
The debate regarding nutritional support in critically ill neonates is ongoing. Therefore, further research is needed to contribute to this knowledge.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Protein: reduced to 1.2 gram/kg/day
Time frame: 7 days after diagnosed as critically ill
Number of Deaths Occurring in the First 7 Days Post-Randomization
Time frame: 72 to 96 hours
The critically ill neonates which resolved from the acute phase of critical condition
Indonesia University
Other
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