Prevention of Refeeding Syndrome

NCT06589479 | Not Yet Recruiting

• 1 other identifier: refeeding syndrome
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine effects of different caloric density intake in prevention of refeeding syndrome in critically ill children

Conditions

Refeeding Syndrome

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  Baseline

• Investigation

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

  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.

  Baseline

Eligibility Criteria

• Age: 1 Month - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.\[11\]

You may not qualify if:

• Children below one month and above 5 years.
• Carless or lack of compliance of parents or psychological problems.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• 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.

  PMID: 32115791 BACKGROUND

• 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.

  PMID: 21102317 BACKGROUND

MeSH Terms

Conditions

Refeeding Syndrome

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Shimaa Ahmed Mohamed Khamis

CONTACT

01140427642; shimaaahmed44551@gmail.com

Duaa Mohammad Raafat

CONTACT

0122 311 2124; duaa_raafat@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 71515,Assiut

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09