Skip to main content
OpenTrials
Completed

NCT Number: NCT07801040

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

72 hour–1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ciptomangunkusumo Public Hospital

Jakarta Pusat, DKI Jakarta, 12810, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • postmenstrual age >32 weeks old
  • actual weight >1.500 gram

Exclusion criteria

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

Treatment and study plan

Amino acid infusion

Dietary Supplement

Protein: reduced to 1.2 gram/kg/day

Primary outcomes

  1. Number of Participants with Mortality

    Time frame: 7 days after diagnosed as critically ill

    Number of Deaths Occurring in the First 7 Days Post-Randomization

Secondary outcomes

  1. Duration of the Acute Phase Critically Ill Neonates

    Time frame: 72 to 96 hours

    The critically ill neonates which resolved from the acute phase of critical condition

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.