Refeeding SyndromeNCT06589479
Prevention of Refeeding Syndrome
An observational study of Refeeding Syndrome, run by Assiut University.
Trial summary
To determine effects of different caloric density intake in prevention of refeeding syndrome in critically ill children Read more about this study
- Who is it for?
- Ages 1 month to 5 years
- Conditions the study is for
- Refeeding Syndrome
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 31 Mar 2026
- Phase
- Observational
- 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 month to 5 years
- All sexes
- Child
Study population: patients with Conditions that place critically ill children at high risk for refeeding syndrome. Clinical conditions Chronic critical illness (e.g., congenital heart disease) . Advanced neurologic impairment eating disorders (e.g., anorexia nervosa) . Dysphagia Gastrointestinal dysmotility Malabsorption (e.g., short bowel syndrome, inflammatory bowel disease, chronic pancreatitis, cystic fibrosis) . Malignancy Child abuse Significant vomiting and diarrhea Unintentional . weight loss of \>5%-10% of body weight in 1-6 months . Prolonged fasting \>7-10 days . Inadequate nutritional intake for \>10 day
Who may be able to join
- Chidren from one month up to less than 5 years.
- Starvation (long term parenteral or IV fluid) for at least 3 days.
- Patients at risk of refeeding syndrome according to ASPEN criteria.[11]
Who cannot join
- Children below one month and above 5 years.
- Carless or lack of compliance of parents or psychological problems.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Different Caloric Density Intake in Prevention of Refeeding Syndrome in Critically Ill Children
To determine effects of different caloric density intake in prevention of refeeding syndrome in critically ill children
Read the detailed description
Refeeding syndrome, a critical condition in undernourished patients, is characterized by metabolic and electrolyte imbalances that occur upon reintroducing nutrition after a period of prolonged fasting which can lead to a sharp increase in morbidity and mortality rates following their release and the resumption of a normal diet. The occurrence of refeeding syndrome is well-documented in conditions such as anorexia nervosa. However, its prevalence among critically ill pediatric patients remains unclear. These patients often suffer from undernutrition due to chronic llnesses,various congenital and acquired diseases, malabsorption, or child abuse [2] There is an increasing awareness of the unexpectedly high prevalence of undernutrition and refeeding syndrome in this population. Studies indicate that between 13% and 20% of patients admitted to pediatric critical care units are undernourished [3] The early initiation of enteral nutrition is often recommended for its overall benefits in critically ill children However, it may inadvertently increase the risk of refeeding syndrome. Extended periods of starvation eventually result in the depletion of stored energy, along with a critical reduction in micronutrients and electrolytes, particularly phosphate, potassium, and magnesium. [5] Upon refeeding, there is an immediate transition from a catabolic to an anabolic state, marked by a rapid increase in caloric intake and a subsequent rise in insulin secretion. This increase in insulin enhances glycolysis-the process of breaking down glucose for energy. The resulting spike in insulin levels can lead to hypoglycemia and promote the transfer of electrolytes from the extracellular to the intracellular space. This movement can significantly reduce extracellular concentrations of potassium, phosphate, magnesium, and thiamine, which acts as a coenzyme. Given the pre-existing deficiencies in these electrolytes and micronutrients due to prolonged starvation, their levels can quickly fall as they are consumed during the metabolic response to refeeding. This abrupt change can precipitate severe complications associated with refeeding syndrome, which stem from imbalances and deficiencies in electrolyte and micronutrient levels Conditions that place critically ill children at high risk for refeeding syndrome . Clinical conditions Chronic critical illness (e.g., congenital heart disease) . Advanced neurologic impairment Eating disorders(e.g., anorexia nervosa) . Dysphagia Gastrointestinal dysmotility Malabsorption (e.g., short bowel syndrome, inflammatory bowel disease, chronic pancreatitis, cystic fibrosis) . Malignancy Child abuse Significant vomiting and diarrhea Unintentional . weight loss of 5%-10% of body weight in 1-6 months . Prolonged fasting \>7-10 days . Inadequate nutritional intake for 10 day The clinical presentations of refeeding syndrome, which typically manifest in the initial days of nutritional reintroduction, include disturbances in fluid balance, hypoglycemia, hypophosphatemia, hypomagnesemia, hypokalemia, and thiamine deficiency. This syndrome can lead to a range of symptoms that affect the neurological, cardiac, hematological, and gastrointestinal systems, primarily due to electrolyte imbalances. To manage refeeding syndrome in at-risk patients, a gradual and cautious reintroduction of nutrition is advised. The cornerstone of reintroducing nutrition is to incrementally increase caloric intake over a period of several days. It is crucial to monitor serum electrolytes, particularly phosphorus, potassium, and magnesium, and provide supplementation as necessary. If patients exhibit signs of intolerance to the calories despite these precautions, it is advisable to temporarily reduce or maintain the caloric intake at its current level. Once the patients condition has stabilized, a careful and gradual increase in caloric intake may be continued. Additionally, thiamine supplementation is important due to its essential role in carbohydrate metabolism.
- Conditions
- Refeeding Syndrome
- Medical subject headings
- Refeeding Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of refeeding syndrome in critically ill children
Describe the pathophysiology of refeeding syndrome, and provide practical recommendations for its preventio in paediatric intensive care units (PICUs). The refeeding syndrome appears in patients who have had a reintroduced and/or increase caloric intake after a period of restricted or no caloric intake. It is manifested by a decrease in one or many electrolytes (potassium, magnesium and/or phosphorous), a thiamine deficiency and/or sodium retention. Despite the lack of evidence, the patients most at risk for refeeding syndrome seem to be malnourished children and those with restricted nutritional intake for more than 7 days. On admission to PICU, nutritional status should be assessed, this will include anthropometric measurements (weight and height z-score, mid upper arm circumference and head circumference in young children) and a diet history.
Measured: Baseli
Methods
Data of the patients will be collected in the form of full history taking:
Personal history:(age,sex) demographics including residence and socioeconomic status.
Nutritional history : type of feeding and its concentration, frequency, amount And if there is any intolerance . Perinatal history(full term or preterm, type of delivery, NICU admission). Present history(disease type, onset, course \& duration) Feeding history(breast feeding, suckling power \& formula feeding). Calories will calculated in different categories patients. Daily monitoring weight by intake, output
Measured: Baseline
Investigation
- CBC
- Random blood glucose
- Electrolyte /24 hours
- Liver function
- kidney function
- If other investigation or imaging study already done will be recorded.
Measured: Baseline
Sample Size Calculation
Based on determining the main outcome variable, The estimated minimum required sample size is 50 patients .
The sample size was calculated using Epi-info version 7 software, based on the following assumptions:
Main outcome variable is to determine effects of different caloric density intake in management of refeeding syndrome in critically ill children Based on literature review ([10] we hypothesized to find medium effect size, and based on the percentage confidence limits of 6% and a Confidence level=80% .
Based on determining the main outcome variable, The estimated minimum required sample size is 50 patients .
The sample size was calculated using Epi-info version 7 software, based on the following assumptions:
Main outcome variable is to determine effects of different caloric density intake.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Refeeding SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Ahmed Mohamed Khamis, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589479
- Sponsor's protocol ID
- refeeding syndrome
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
da Silva JSV, Seres DS, Sabino K, Adams SC, Berdahl GJ, Citty SW, Cober MP, Evans DC, Greaves JR, Gura KM, Michalski A, Plogsted S, Sacks GS, Tucker AM, Worthington P, Walker RN, Ayers P; Parenteral Nutrition Safety and Clinical Practice Committees, American Society for Parenteral and Enteral Nutrition. ASPEN Consensus Recommendations for Refeeding Syndrome. Nutr Clin Pract. 2020 Apr;35(2):178-195. doi: 10.1002/ncp.10474. Epub 2020 Mar 2.
PubMed 32115791Byrnes MC, Stangenes J. Refeeding in the ICU: an adult and pediatric problem. Curr Opin Clin Nutr Metab Care. 2011 Mar;14(2):186-92. doi: 10.1097/MCO.0b013e328341ed93.
PubMed 21102317
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Caloric Density Intake in Prevention of Refeeding Syndrome in Critically Ill Children
- ClinicalTrials.gov ID
- NCT06589479
- Acronym / sponsor ID
- refeeding syndrome
- Conditions
- Refeeding Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 19 Sep 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.
To determine effects of different caloric density intake in prevention of refeeding syndrome in critically ill children
Detailed description
Refeeding syndrome, a critical condition in undernourished patients, is characterized by metabolic and electrolyte imbalances that occur upon reintroducing nutrition after a period of prolonged fasting which can lead to a sharp increase in morbidity and mortality rates following their release and the resumption of a normal diet. The occurrence of refeeding syndrome is well-documented in conditions such as anorexia nervosa. However, its prevalence among critically ill pediatric patients remains unclear. These patients often suffer from undernutrition due to chronic llnesses,various congenital and acquired diseases, malabsorption, or child abuse [2] There is an increasing awareness of the unexpectedly high prevalence of undernutrition and refeeding syndrome in this population. Studies indicate that between 13% and 20% of patients admitted to pediatric critical care units are undernourished [3] The early initiation of enteral nutrition is often recommended for its overall benefits in critically ill children However, it may inadvertently increase the risk of refeeding syndrome. Extended periods of starvation eventually result in the depletion of stored energy, along with a critical reduction in micronutrients and electrolytes, particularly phosphate, potassium, and magnesium. [5] Upon refeeding, there is an immediate transition from a catabolic to an anabolic state, marked by a rapid increase in caloric intake and a subsequent rise in insulin secretion. This increase in insulin enhances glycolysis-the process of breaking down glucose for energy. The resulting spike in insulin levels can lead to hypoglycemia and promote the transfer of electrolytes from the extracellular to the intracellular space. This movement can significantly reduce extracellular concentrations of potassium, phosphate, magnesium, and thiamine, which acts as a coenzyme. Given the pre-existing deficiencies in these electrolytes and micronutrients due to prolonged starvation, their levels can quickly fall as they are consumed during the metabolic response to refeeding. This abrupt change can precipitate severe complications associated with refeeding syndrome, which stem from imbalances and deficiencies in electrolyte and micronutrient levels Conditions that place critically ill children at high risk for refeeding syndrome . Clinical conditions Chronic critical illness (e.g., congenital heart disease) . Advanced neurologic impairment Eating disorders(e.g., anorexia nervosa) . Dysphagia Gastrointestinal dysmotility Malabsorption (e.g., short bowel syndrome, inflammatory bowel disease, chronic pancreatitis, cystic fibrosis) . Malignancy Child abuse Significant vomiting and diarrhea Unintentional . weight loss of 5%-10% of body weight in 1-6 months . Prolonged fasting \>7-10 days . Inadequate nutritional intake for 10 day The clinical presentations of refeeding syndrome, which typically manifest in the initial days of nutritional reintroduction, include disturbances in fluid balance, hypoglycemia, hypophosphatemia, hypomagnesemia, hypokalemia, and thiamine deficiency. This syndrome can lead to a range of symptoms that affect the neurological, cardiac, hematological, and gastrointestinal systems, primarily due to electrolyte imbalances. To manage refeeding syndrome in at-risk patients, a gradual and cautious reintroduction of nutrition is advised. The cornerstone of reintroducing nutrition is to incrementally increase caloric intake over a period of several days. It is crucial to monitor serum electrolytes, particularly phosphorus, potassium, and magnesium, and provide supplementation as necessary. If patients exhibit signs of intolerance to the calories despite these precautions, it is advisable to temporarily reduce or maintain the caloric intake at its current level. Once the patients condition has stabilized, a careful and gradual increase in caloric intake may be continued. Additionally, thiamine supplementation is important due to its essential role in carbohydrate metabolism.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Age groups
- Child
- Study population
- patients with Conditions that place critically ill children at high risk for refeeding syndrome. Clinical conditions Chronic critical illness (e.g., congenital heart disease) . Advanced neurologic impairment eating disorders (e.g., anorexia nervosa) . Dysphagia Gastrointestinal dysmotility Malabsorption (e.g., short bowel syndrome, inflammatory bowel disease, chronic pancreatitis, cystic fibrosis) . Malignancy Child abuse Significant vomiting and diarrhea Unintentional . weight loss of \>5%-10% of body weight in 1-6 months . Prolonged fasting \>7-10 days . Inadequate nutritional intake for \>10 day
Key inclusion criteria (3 listed)
- Chidren from one month up to less than 5 years.
- Starvation (long term parenteral or IV fluid) for at least 3 days.
- Patients at risk of refeeding syndrome according to ASPEN criteria.[11]
Key exclusion criteria (2 listed)
- Children below one month and above 5 years.
- Carless or lack of compliance of parents or psychological problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevention of refeeding syndrome in critically ill children
Time frame: Baseli
Describe the pathophysiology of refeeding syndrome, and provide practical recommendations for its preventio in paediatric intensive care units (PICUs). The refeeding syndrome appears in patients who have had a reintroduced and/or increase caloric intake after a period of restricted or no caloric intake. It is manifested by a decrease in one or many electrolytes (potassium, magnesium and/or phosphorous), a thiamine deficiency and/or sodium retention. Despite the lack of evidence, the patients most at risk for refeeding syndrome seem to be malnourished children and those with restricted nutritional intake for more than 7 days. On admission to PICU, nutritional status should be assessed, this will include anthropometric measurements (weight and height z-score, mid upper arm circumference and head circumference in young children) and a diet history.
Methods
Time frame: Baseline
Data of the patients will be collected in the form of full history taking: Personal history:(age,sex) demographics including residence and socioeconomic status. Nutritional history : type of feeding and its concentration, frequency, amount And if there is any intolerance . Perinatal history(full term or preterm, type of delivery, NICU admission). Present history(disease type, onset, course \& duration) Feeding history(breast feeding, suckling power \& formula feeding). Calories will calculated in different categories patients. Daily monitoring weight by intake, output
Investigation
Time frame: Baseline
* CBC * Random blood glucose * Electrolyte /24 hours * Liver function * kidney function * If other investigation or imaging study already done will be recorded.
Sample Size Calculation
Time frame: Baseline
Based on determining the main outcome variable, The estimated minimum required sample size is 50 patients . The sample size was calculated using Epi-info version 7 software, based on the following assumptions: Main outcome variable is to determine effects of different caloric density intake in management of refeeding syndrome in critically ill children Based on literature review ([10] we hypothesized to find medium effect size, and based on the percentage confidence limits of 6% and a Confidence level=80% . Based on determining the main outcome variable, The estimated minimum required sample size is 50 patients . The sample size was calculated using Epi-info version 7 software, based on the following assumptions: Main outcome variable is to determine effects of different caloric density intake.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 32115791da Silva JSV, Seres DS, Sabino K, Adams SC, Berdahl GJ, Citty SW, Cober MP, Evans DC, Greaves JR, Gura KM, Michalski A, Plogsted S, Sacks GS, Tucker AM, Worthington P, Walker RN, Ayers P; Parenteral Nutrition Safety and Clinical Practice Committees, American Society for Parenteral and Enteral Nutrition. ASPEN Consensus Recommendations for Refeeding Syndrome. Nutr Clin Pract. 2020 Apr;35(2):178-195. doi: 10.1002/ncp.10474. Epub 2020 Mar 2.
- Results publication: PubMed 21102317Byrnes MC, Stangenes J. Refeeding in the ICU: an adult and pediatric problem. Curr Opin Clin Nutr Metab Care. 2011 Mar;14(2):186-92. doi: 10.1097/MCO.0b013e328341ed93.
Related trials for Refeeding Syndrome
Not yet recruitingObservational study
Respiratory Quotient and Phosphate Changes During Early Critical Illness
Refeeding Syndrome, Critical Illness
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3-Dimensional Optical Scanning to Assess and Monitor Malnutrition in Eating Disorders (3D-ED) Study
Anorexia in Adolescence, Anorexia Nervosa
Not yet recruitingObservational study
Gastrointestinal Hormones and Metabolomic Profiling Following Mixed-Meal Tolerance Tests in Patients at Risk of Refeeding Syndrome
Refeeding Syndrome, Malnutrition
Active, not recruitingPhase 1
Slow Introduction of Nutrition for Ill Malnourished Children
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Recruiting
Comparing High-protein Vs. Standard Protein Nutritional Support in Critically Ill Patients At Risk for Refeeding Syndrome
Critical Illness, Malnutrition
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Refeeding Syndrome, run by Assiut University.
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 3 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shimaa Ahmed Mohamed Khamis (01140427642, shimaaahmed44551@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of refeeding syndrome in critically ill children (time frame: Baseli). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06589479, which also lists 2 linked publications.
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 19 Sep 2024.