An interventional study of Amino acid infusion in Critical Illness and Parenteral Nutrition, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 72 Hours to 1 Month. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Indonesia University · Not applicable, Interventional, and Treatment
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.
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.
1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.
This study's enrollment of 52 is below the median of 90 across 926 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Indonesia University is the lead sponsor of 446 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
Reduced to 1.2 gram/kg/day
Dietary Supplement: Amino acid infusion
\>2 gram/kg/day or according to previous dose
Protein: reduced to 1.2 gram/kg/day
Number of Participants with Mortality
Number of Deaths Occurring in the First 7 Days Post-Randomization
Time frame: 7 days after diagnosed as critically ill
Duration of the Acute Phase Critically Ill Neonates
The critically ill neonates which resolved from the acute phase of critical condition
Time frame: 72 to 96 hours
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Oct 2025 to primary completion in May 2026, 7 months.
Of 400 non-industry interventional studies with no phase under Critical Illness, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's 7 months is below that.
Counting every sponsor, half of 404 studies reached it within 21 months; a quarter within 12 and three quarters within 40.
Critical Illness covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Amino Acids