An interventional study of Pulmonary-Specific Enteral Nutrition and Standard Hospital Enteral Nutrition in Pneumonia, sponsored by Universitas Indonesia. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Universitas Indonesia · Not applicable, Interventional, and Supportive care
Pneumonia is a major cause of critical illness and respiratory failure, particularly among patients requiring invasive mechanical ventilation. These patients frequently experience systemic inflammation and metabolic disturbances, which can be assessed using the neutrophil-to-lymphocyte ratio (NLR) and blood lactate levels. Pulmonary-specific enteral nutrition, characterized by a lower carbohydrate and higher fat composition, may help improve respiratory metabolism and modulate inflammatory responses.
This double-blind, randomized controlled trial aimed to evaluate the effects of pulmonary-specific enteral nutrition compared with standard enteral nutrition on NLR and blood lactate levels in adult patients with pneumonia requiring invasive mechanical ventilation. Participants were randomly assigned to receive either pulmonary-specific enteral nutrition or standard enteral nutrition. NLR and blood lactate levels were measured on days 1, 3, and 5 to assess changes in inflammatory and metabolic parameters during the intervention period.
This study was a single-center, double-blind, parallel-group randomized controlled trial conducted in the Intensive Care Unit (ICU) and High Care Unit (HCU) of Cipto Mangunkusumo National Hospital, Jakarta, Indonesia, between January and December 2025.
The study evaluated whether pulmonary-specific enteral nutrition could influence systemic inflammatory and metabolic responses in critically ill adults with pneumonia requiring invasive mechanical ventilation. Eligible patients were adults aged 18-80 years with a diagnosis of pneumonia based on clinical, radiological, and laboratory findings, including community-acquired pneumonia, hospital-acquired pneumonia, and ventilator-associated pneumonia.
Participants were randomly assigned in a 1:1 ratio to receive pulmonary-specific enteral nutrition (Pulmosol®) or standard hospital enteral nutrition. Randomization was performed using a computer-generated block randomization sequence. Both formulas were provided in identical packaging to maintain blinding of investigators, healthcare providers, and outcome assessors.
Enteral nutrition was administered through a nasogastric or orogastric tube. Energy requirements were assessed using indirect calorimetry when available or estimated at approximately 25-30 kcal/kg/day. Nutritional delivery was initiated gradually, targeting approximately 70% of estimated energy requirements during the first three days and advancing toward the full caloric target thereafter. The protein intake target was approximately 1.2-1.5 g/kg/day.
The study assessed the neutrophil-to-lymphocyte ratio (NLR) as an inflammatory biomarker and blood lactate concentration as a metabolic biomarker. Measurements were performed on study days 1, 3, and 5. Changes in these parameters were evaluated within each treatment group and compared between the two groups.
The planned statistical approach included the Friedman test for within-group repeated measurements and the Mann-Whitney U test for between-group comparisons of changes in biomarker levels. Statistical significance was evaluated using a two-sided threshold of p \< 0.05.
The study was approved by the Ethics Committee of the Faculty of Medicine, Universitas Indonesia-Cipto Mangunkusumo Hospital (KET-1383/UN2.F1/ETIK/PPM.00.02/2023). Written informed consent was obtained from participants or their legally authorized representatives before enrollment.
2,072 studies on the registry are indexed under Pneumonia; 286 are open to participants now.
This study's enrollment of 56 is below the median of 107 across 1,263 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Universitas Indonesia is the lead sponsor of 27 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of severe pneumonia, including community-acquired pneumonia (CAP), hospital-acquired pneumonia (HAP), or ventilator-associated pneumonia (VAP), based on ATS/IDSA criteria or a PaO2/FiO2 ratio \< 200 mmHg, with all of the following:
Exclusion Criteria:
Participants assigned to this group received pulmonary-specific enteral nutrition (Pulmosol®) through an enteral feeding tube. The formula was administered as the assigned nutritional intervention without combination with the standard hospital enteral formula. Energy delivery was individualized according to clinical requirements and feeding tolerance during the five-day observation period.
Other: Pulmonary-Specific Enteral Nutrition
Participants assigned to this group received the standard hospital enteral nutrition formula (FRS-CLLM) through an enteral feeding tube. Nutritional delivery was individualized according to energy requirements and feeding tolerance, following routine nutritional management during the five-day observation period.
Other: Standard Hospital Enteral Nutrition
Pulmonary-specific enteral formula (Pulmosol®) administered through a nasogastric or other enteral feeding tube as the sole assigned enteral formula. Nutritional targets were individualized based on estimated energy requirements, with gradual advancement of feeding toward the full caloric target. The formula contains carbohydrate, protein, fat, and omega-3 fatty acids. Nutritional tolerance was monitored throughout the intervention.
Also known as: Pulmosol
Standard hospital enteral nutrition formula, administered through a nasogastric or other enteral feeding tube according to individually estimated energy and protein requirements. Nutritional delivery was progressively adjusted based on clinical condition and feeding tolerance during the five-day observation period.
Change in Neutrophil-to-Lymphocyte Ratio (NLR) From Baseline to Day 5
The neutrophil-to-lymphocyte ratio (NLR) was calculated by dividing the absolute neutrophil count by the absolute lymphocyte count obtained from a complete blood count. NLR was assessed at baseline (Day 1), Day 3, and Day 5. The outcome evaluates the change in NLR between baseline and Day 5, with additional assessment of changes between Days 1-3 and Days 3-5. NLR is a dimensionless ratio.
Time frame: Baseline (Day 1) and Day 5
Change in Blood Lactate Levels From Baseline to Day 5
Blood lactate concentration was measured in mmol/L at baseline (Day 1), Day 3, and Day 5. The outcome evaluates the absolute change in blood lactate concentration from baseline to Day 5, with additional assessment of changes between Days 1-3 and Days 3-5. Changes were compared between the pulmonary-specific enteral nutrition and standard enteral nutrition groups.
Time frame: Baseline (Day 1) and Day 5
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2025 to primary completion in Jun 2026, 10 months.
Of 293 non-industry interventional studies with no phase under Pneumonia, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's 10 months is below that.
Counting every sponsor, half of 303 studies reached it within 21 months; a quarter within 10 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universitas Indonesia