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Not yet recruitingNCT06589479Updated Sep 19, 2024

Prevention of Refeeding Syndrome

An observational study in Refeeding Syndrome, sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Month to 5 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
50
Ages
1 Month to 5 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Refeeding Syndrome

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In context

Refeeding Syndrome

24 studies on the registry are indexed under Refeeding Syndrome; 7 are open to participants now.

This study's planned enrollment of 50 is below the median of 57 across 16 observational studies indexed under Refeeding Syndrome.

Browse Refeeding Syndrome studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Month to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

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.

Inclusion criteria

  1. Chidren from one month up to less than 5 years.
  2. Starvation (long term parenteral or IV fluid) for at least 3 days.
  3. Patients at risk of refeeding syndrome according to ASPEN criteria.[11]

Exclusion criteria

Exclusion Criteria:

  1. Children below one month and above 5 years.
  2. Carless or lack of compliance of parents or psychological problems.
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
50 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseli

  2. 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

    Time frame: Baseline

  3. Investigation

    * CBC * Random blood glucose * Electrolyte /24 hours * Liver function * kidney function * If other investigation or imaging study already done will be recorded.

    Time frame: Baseline

  4. 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.

    Time frame: Baseline

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Study locations

No study locations are listed for this record.

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References and documents

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. Erratum In: Nutr Clin Pract. 2020 Jun;35(3):584-585. doi: 10.1002/ncp.10491. PubMed 32115791 ↗
  • Byrnes 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 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2024; primary completion for Dec 2025, 14 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 5, 2024
First posted
Sep 19, 2024
StartEst.
Oct 1, 2024
Primary completionEst.
Dec 31, 2025
CompletionEst.
Mar 31, 2026
Last update
Sep 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06589479
Lead sponsor
Assiut University
Responsible party
Shimaa Ahmed Mohamed Khamis (71515,Assiut, Assiut University) — Principal investigator
First posted
Sep 19, 2024
Start date
Oct 1, 2024 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Mar 31, 2026 (estimated)
Last update
Sep 19, 2024

Study contacts

Shimaa Ahmed Mohamed Khamis
Contact
shimaaahmed44551@gmail.com
01140427642
Duaa Mohammad Raafat
Contact
duaa_raafat@aun.edu.eg
0122 311 2124

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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