Prevention of Refeeding Syndrome
ConditionRefeeding Syndrome
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-5
SponsorAssiut University
About this trial
To determine effects of different caloric density intake in prevention of refeeding syndrome in critically ill children
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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]
Disqualifiers
Children below one month and above 5 years.
Carless or lack of compliance of parents or psychological problems.
Trial 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
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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
Baseli2
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
Baseline3
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
Baseline4
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
BaselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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