Critical IllnessNCT07801040
Protein Restriction In Parenteral Nutrition For Critically Ill Neonates During The Acute Phase: A Preliminary Study
A study testing Amino acid infusion in people with Critical Illness and Parenteral Nutrition, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 72 hours to 1 month
- Conditions the study is for
- Critical Illness, Parenteral Nutrition
- What is being tested?
- Amino acid infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteIndonesia
- Study dates
- 17 Oct 2025to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 72 hours to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- postmenstrual age >32 weeks old
- actual weight >1.500 gram
Who cannot join
- given <1 gram/kg/day of protein
- critical congenital malformation
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Ciptomangunkusumo Public Hospital
Jakarta Pusat, DKI Jakarta, 12810
About this 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.
Read the 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.
- Conditions
- Critical Illness, Parenteral Nutrition
- Being tested
- Amino acid infusion
- Keywords
- Critical ill neonates, Neonatal post-operative care, Protein restriction
- Medical subject headings
- Critical Illness, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino acid infusionDietary supplement
Protein: reduced to 1.2 gram/kg/day
| Study group | Role | What they receive |
|---|---|---|
| Protrein restriction | Experimental | Reduced to 1.2 gram/kg/day Receives: Dietary Supplement: Amino acid infusion |
| No protein restriction | No intervention | >2 gram/kg/day or according to previous dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Mortality
Number of Deaths Occurring in the First 7 Days Post-Randomization
Measured: 7 days after diagnosed as critically ill
Secondary outcomes (1)
Duration of the Acute Phase Critically Ill Neonates
The critically ill neonates which resolved from the acute phase of critical condition
Measured: 72 to 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start17 Oct 2025
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Putri Maharani Tristanita Marsubrin, MD, PhD, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801040
- Sponsor's protocol ID
- 25-09-1313
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein Restriction In Parenteral Nutrition For Critically Ill Neonates During The Acute Phase: A Preliminary Study
- ClinicalTrials.gov ID
- NCT07801040
- Acronym / sponsor ID
- 25-09-1313
- Conditions
- Critical Illness, Parenteral Nutrition
- Keywords
- Critical ill neonates, Neonatal post-operative care, Protein restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protrein restriction | Experimental | Dietary Supplement: Amino acid infusionReduced to 1.2 gram/kg/day |
| No protein restriction | No intervention | –>2 gram/kg/day or according to previous dose |
Who may qualify
- Ages
- 72 hours to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- postmenstrual age >32 weeks old
- actual weight >1.500 gram
Key exclusion criteria (2 listed)
- given <1 gram/kg/day of protein
- critical congenital malformation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amino acid infusionProtein: reduced to 1.2 gram/kg/day | Dietary supplement | Protrein restriction |
Primary outcome
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
1 secondary outcome
Duration of the Acute Phase Critically Ill Neonates
Time frame: 72 to 96 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amino acid infusion in people with Critical Illness and Parenteral Nutrition, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Mortality (time frame: 7 days after diagnosed as critically ill). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.