Enteral NutritionNCT06411873
The Effect of High Protein Enteral Nutrition on Critically Ill Postoperative Children
A study testing Intervention Group in people with Enteral Nutrition and Postoperative, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is o determine the feasibility and efficacy of high enteral protein in critically ill postoperative children. It will also learn about the safety of high enteral protein for critically ill postoperative children. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Enteral Nutrition, Postoperative, Critically Ill Children
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteIndonesia
- Study dates
- 30 Jul 2024to 30 Oct 2024
- 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 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Critically ill postoperative children (age 1 to 5 years of age)
- Hemodynamically stable within 48 hours postoperative
- The patient receives enteral nutrition within 48 hours postoperative
- The patient can undergo observation and examination for up to 72 hours after enteral nutrition therapy
- The parents/guardians are willing to participate in the study by signing the informed consent
Who cannot join
- Patients with absolute contraindications (paralytic/mechanical ileus, gastrointestinal obstruction, gastrointestinal perforation) or relative contraindications (gastrointestinal dysmotility, necrotizing enterocolitis, toxic megacolon, extensive peritonitis, gastrointestinal bleeding, gastrointestinal fistula) to enteral nutrition administration.
- Patients with a history of cow's milk allergy or using special formula milk.
- Patients still receiving breast milk (breastfeeding).
- Patients at high risk of refeeding syndrome according to ASPEN consensus
- Patients with acute or chronic kidney disorders.
- Patients with liver disorders.
Show all 11Show fewer
- Patients with diabetes mellitus.
- Patients with inborn errors of metabolism.
- Patients receiving total parenteral nutrition.
- Patients requiring continuous life support devices such as continuous renal replacement therapy (CRRT) or extracorporeal membrane oxygenation (ECMO).
- Nitrogen balance cannot be measured (patients with drainage production >1 ml/kg/hour or bleeding >10% of total blood volume at the time of enteral nutrition initiation).
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
RSUPN Dr. Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: The Effect of High Protein Enteral Nutrition on Critically Ill Postoperative Children: A Study of Nitrogen Balance and Intestinal Fatty Acid Binding Protein
The goal of this clinical trial is o determine the feasibility and efficacy of high enteral protein in critically ill postoperative children. It will also learn about the safety of high enteral protein for critically ill postoperative children. The main questions it aims to answer are:
Does high enteral protein improve nitrogen balance in critically ill postoperative children? Does high enteral protein reduce levels of Intestinal Fatty Acid Binding Protein (I-FABP) in critically ill postoperative children?
Read more
Researchers will compare high enteral protein to a standard enteral protein to see if high enteral protein works to improve nitrogen balance and reduces levels of Intestinal Fatty Acid Binding Protein (I-FABP) in critically ill postoperative children.
Participants will:
Take high enteral protein or standard enteral protein for 72 hours The nitrogen balance and I-FABP levels will be assessed both before and after enteral feeding.
Monitoring and reporting of adverse events and serious adverse events will be conducted in accordance with good clinical practice guidelines.
Read the detailed description
Postoperative care in critically ill children often involves careful attention to nutritional support to optimize recovery and outcomes. Among the various nutritional interventions, high protein enteral nutrition has gained significant attention for its potential benefits in this population. Adequate protein intake is essential for wound healing, immune function, and muscle preservation, all of which are crucial aspects of recovery following surgery in critically ill children.
High protein enteral nutrition offers a targeted approach to meet the increased protein requirements during the postoperative period. By providing a concentrated source of protein directly into the gastrointestinal tract, it bypasses potential barriers associated with oral intake and facilitates nutrient absorption in a controlled manner. Additionally, enteral nutrition is preferred over parenteral nutrition due to its lower risk of complications and potential to maintain gut integrity and function.
Despite its theoretical advantages, the clinical efficacy of high protein enteral nutrition in critically ill postoperative children remains an area of ongoing research. Studies investigating its impact on nitrogen balance, muscle protein synthesis, immune function, and clinical outcomes are essential for guiding nutritional practices in this vulnerable population.
This study aim to evaluate the effect of high protein enteral nutrition on critically ill postoperative children, with a focus on assessing nitrogen balance and intestinal fatty acid binding protein levels. Through comprehensive analysis, potential benefits and challenges associated with this nutritional intervention will be identified, ultimately informing evidence-based nutritional strategies for optimizing postoperative care in critically ill pediatric patients.
- Conditions
- Enteral Nutrition, Postoperative, Critically Ill Children
- Being tested
- Control Group, Intervention Group
- Keywords
- Proteins, Enteral, Critically ill children, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupDietary supplement
Composition of formula per 100 mL : energy (100 kcal), protein (3 g), carbohydrate (13.54 g), lipids (3.93 g), protein energy ratio/PER 12%, osmolarity (310 mOsm/L), renal solute load/RSL (27.5 mOsm/100 kcal)
Intervention GroupDietary supplement
Composition of formula per 100 mL : energy (105.5 kcal), protein (4.35 g), carbohydrate (13.54 g), lipids (3.93 g), protein energy ratio/PER 16.5%, osmolarity (333.5 mOsm/L), renal solute load/RSL (27.7 mOsm/100 kcal)
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | The patients included in the control group received the customary protein amount and were fed a standard formula (Pediacomplete, Abbot, Indonesia) Receives: Dietary Supplement: Control Group |
| Intervention Group | Experimental | The patients included in the intervention group received the same formula like control group with the addition of modular protein supplement PURO ISOPRO WPI Whey Isolate PLAIN, Puro Pure Nutrition, Sukoharjo, Indonesia (BPOM : MD 862312050010) Receives: Dietary Supplement: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nitrogen Balance
The Nitrogen Balance was calculated by subtracting nitrogen losses from the nitrogen intake, including urinary, faecal and miscellaneous losses (dermal, sweat, integumentary) with the following formula:
Nitrogen Balance (mg/kg) = nitrogen intake (mg/kg) -(total urine nitrogen (mg/kg) + 75 mg/kg) where 75 mg/kg represents faecal and miscellaneous nitrogen losses. The total urinary nitrogen (TUN) excretion was estimated as the urinary urea nitrogen (UUN) concentration (mg/kg) × 1.25 to include nitrogen losses in the form of ammonia, creatinine, uric acid and amino acids. The UUN check from 24 hours urine sample.
Measured: Nitrogen balance will be assessed both before and after 72 hours enteral feeding
I-FABP Levels
The blood samples for measuring I-FABP levels (pg/mL) will be securely transported to and processed at Prodia Laboratory.
Measured: I-FABP levels will be assessed both before and after 72 hours enteral feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start30 Jul 2024
- Primary completion10 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral NutritionStudies 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
- Model description
- This trial is an interventional study with two arms. Participants will be randomised to high enteral protein or standard enteral protein. For both trial arms, participants will be provided with enteral nutrition (EN) as per standard of care.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. dr. Irene Yuniar, Sp.A(K), Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411873
- Sponsor's protocol ID
- 24779
- Status last verified
- Dec 2024
- First submitted
- 7 May 2024
- Last updated
- 10 Dec 2024
- 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 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High Protein Enteral Nutrition on Critically Ill Postoperative Children: A Study of Nitrogen Balance and Intestinal Fatty Acid Binding Protein
- ClinicalTrials.gov ID
- NCT06411873
- Acronym / sponsor ID
- 24779
- Conditions
- Enteral Nutrition, Postoperative, Critically Ill Children
- Keywords
- Proteins, Enteral, Critically ill children, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 13 May 2024 (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.
The goal of this clinical trial is o determine the feasibility and efficacy of high enteral protein in critically ill postoperative children. It will also learn about the safety of high enteral protein for critically ill postoperative children. The main questions it aims to answer are:
Does high enteral protein improve nitrogen balance in critically ill postoperative children? Does high enteral protein reduce levels of Intestinal Fatty Acid Binding Protein (I-FABP) in critically ill postoperative children?
Researchers will compare high enteral protein to a standard enteral protein to see if high enteral protein works to improve nitrogen balance and reduces levels of Intestinal Fatty Acid Binding Protein (I-FABP) in critically ill postoperative children.
Participants will:
Take high enteral protein or standard enteral protein for 72 hours The nitrogen balance and I-FABP levels will be assessed both before and after enteral feeding.
Monitoring and reporting of adverse events and serious adverse events will be conducted in accordance with good clinical practice guidelines.
Detailed description
Postoperative care in critically ill children often involves careful attention to nutritional support to optimize recovery and outcomes. Among the various nutritional interventions, high protein enteral nutrition has gained significant attention for its potential benefits in this population. Adequate protein intake is essential for wound healing, immune function, and muscle preservation, all of which are crucial aspects of recovery following surgery in critically ill children.
High protein enteral nutrition offers a targeted approach to meet the increased protein requirements during the postoperative period. By providing a concentrated source of protein directly into the gastrointestinal tract, it bypasses potential barriers associated with oral intake and facilitates nutrient absorption in a controlled manner. Additionally, enteral nutrition is preferred over parenteral nutrition due to its lower risk of complications and potential to maintain gut integrity and function.
Despite its theoretical advantages, the clinical efficacy of high protein enteral nutrition in critically ill postoperative children remains an area of ongoing research. Studies investigating its impact on nitrogen balance, muscle protein synthesis, immune function, and clinical outcomes are essential for guiding nutritional practices in this vulnerable population.
This study aim to evaluate the effect of high protein enteral nutrition on critically ill postoperative children, with a focus on assessing nitrogen balance and intestinal fatty acid binding protein levels. Through comprehensive analysis, potential benefits and challenges associated with this nutritional intervention will be identified, ultimately informing evidence-based nutritional strategies for optimizing postoperative care in critically ill pediatric patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This trial is an interventional study with two arms. Participants will be randomised to high enteral protein or standard enteral protein. For both trial arms, participants will be provided with enteral nutrition (EN) as per standard of care.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Dietary Supplement: Control GroupThe patients included in the control group received the customary protein amount and were fed a standard formula (Pediacomplete, Abbot, Indonesia) |
| Intervention Group | Experimental | Dietary Supplement: Intervention GroupThe patients included in the intervention group received the same formula like control group with the addition of modular protein supplement PURO ISOPRO WPI Whey Isolate PLAIN, Puro Pure Nutrition, Sukoharjo, Indonesia (BPOM : MD 862312050010) |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Critically ill postoperative children (age 1 to 5 years of age)
- Hemodynamically stable within 48 hours postoperative
- The patient receives enteral nutrition within 48 hours postoperative
- The patient can undergo observation and examination for up to 72 hours after enteral nutrition therapy
- The parents/guardians are willing to participate in the study by signing the informed consent
Key exclusion criteria (11 listed)
- Patients with absolute contraindications (paralytic/mechanical ileus, gastrointestinal obstruction, gastrointestinal perforation) or relative contraindications (gastrointestinal dysmotility, necrotizing enterocolitis, toxic megacolon, extensive peritonitis, gastrointestinal bleeding, gastrointestinal fistula) to enteral nutrition administration.
- Patients with a history of cow's milk allergy or using special formula milk.
- Patients still receiving breast milk (breastfeeding).
- Patients at high risk of refeeding syndrome according to ASPEN consensus
- Patients with acute or chronic kidney disorders.
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 |
|---|---|---|
| Control GroupComposition of formula per 100 mL : energy (100 kcal), protein (3 g), carbohydrate (13.54 g), lipids (3.93 g), protein energy ratio/PER 12%, osmolarity (310 mOsm/L), renal solute load/RSL (27.5 mOsm/100 kcal) | Dietary supplement | Control Group |
| Intervention GroupComposition of formula per 100 mL : energy (105.5 kcal), protein (4.35 g), carbohydrate (13.54 g), lipids (3.93 g), protein energy ratio/PER 16.5%, osmolarity (333.5 mOsm/L), renal solute load/RSL (27.7 mOsm/100 kcal) | Dietary supplement | Intervention Group |
Primary outcome
Nitrogen Balance
Time frame: Nitrogen balance will be assessed both before and after 72 hours enteral feeding
The Nitrogen Balance was calculated by subtracting nitrogen losses from the nitrogen intake, including urinary, faecal and miscellaneous losses (dermal, sweat, integumentary) with the following formula: Nitrogen Balance (mg/kg) = nitrogen intake (mg/kg) -(total urine nitrogen (mg/kg) + 75 mg/kg) where 75 mg/kg represents faecal and miscellaneous nitrogen losses. The total urinary nitrogen (TUN) excretion was estimated as the urinary urea nitrogen (UUN) concentration (mg/kg) × 1.25 to include nitrogen losses in the form of ammonia, creatinine, uric acid and amino acids. The UUN check from 24 hours urine sample.
I-FABP Levels
Time frame: I-FABP levels will be assessed both before and after 72 hours enteral feeding
The blood samples for measuring I-FABP levels (pg/mL) will be securely transported to and processed at Prodia Laboratory.
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 10 Dec 2024.
- 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 Intervention Group in people with Enteral Nutrition and Postoperative, 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 5 inclusion and 11 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 10 Dec 2024. 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. Some participants in this study may receive a placebo. 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?
Nitrogen Balance (time frame: Nitrogen balance will be assessed both before and after 72 hours enteral feeding). The study lists 2 primary outcomes in all. 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 10 Dec 2024.