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Protein Restriction In Parenteral Nutrition For Critically Ill Neonates During The Acute Phase: A Preliminary Study

Protein Restriction In Parenteral Nutrition For Critically Ill Neonates During The Acute Phase: A Preliminary Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07801040
Enrollment
52
Registered
2026-09-03
Start date
2025-10-17
Completion date
2026-05-31
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Parenteral Nutrition

Keywords

Critical ill neonates, Neonatal post-operative care, Protein restriction

Brief summary

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.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTAmino acid infusion

Protein: reduced to 1.2 gram/kg/day

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
72 Years to 1 Months
Healthy volunteers
No

Inclusion criteria

* postmenstrual age \>32 weeks old * actual weight \>1.500 gram

Exclusion criteria

* given \<1 gram/kg/day of protein * critical congenital malformation

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with Mortality7 days after diagnosed as critically illNumber of Deaths Occurring in the First 7 Days Post-Randomization

Secondary

MeasureTime frameDescription
Duration of the Acute Phase Critically Ill Neonates72 to 96 hoursThe critically ill neonates which resolved from the acute phase of critical condition

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026