scholarly journals Comparison of the effect of three different protein content enteral diets on serum levels of proteins, nitrogen balance and energy expenditure in critically ill infants: study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Reyes Fernández Montes ◽  
Javier Urbano Villaescusa ◽  
Ángel Carrillo Álvarez ◽  
Ana Vivanco Allende ◽  
María José Solana García ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Energy Expenditure ◽  
Protein Content ◽  
Critically Ill ◽  
Nitrogen Balance ◽  
Controlled Trial ◽  
Serum Levels ◽  
Critically Ill Children ◽  
Protein Balance ◽  
Randomized Controlled

Abstract Background Nutritional support is essential in the care of critically ill children, since malnutrition in this population is associated to increased morbidity and mortality. Injury in patients admitted to pediatric intensive care units (PICU) results in a catabolic state, with augmented protein breakdown, leading to a negative protein balance. Current recommendations about protein prescription in PICU are fundamentally based on expert opinions, with a minimum threshold of 1.5 g/kg/day of protein, although protein needs could be higher in certain subgroups of patients. The main objective of the present study is to examine if the administration of a protein-enriched infant formula increases the serum levels of total proteins, albumin, prealbumin, transferrin, retinol, and improves nitrogen balance; and to analyze the effect of the high-protein diet on energy expenditure. A secondary objective is to register possible secondary effects of the protein-enriched diet. Methods a multicenter prospective randomized controlled trial (RCT) will be performed in three hospitals. Patients meeting inclusion criteria will be randomly allocated to one of three enteral feeding formula with different protein content. Blood and urine test, nitrogen balance assessment and energy expenditure testing by indirect calorimetry will be performed at the beginning of nutrition regimen and at 24 hours, 72 hours and 5-7 days after initiation. The sample size for this trial is estimated as 90 participants, with approximately 30 participants in each group. The data analysis will be by intention to treat. Discussion this RCT will provide new data about the amount of protein needed to improve levels of serum protein and nitrogen balance, surrogate of protein balance, in critically ill infants receiving enteral nutrition.

scholarly journals Comparison of the effect of three different protein content enteral diets on serum levels of proteins, nitrogen balance and energy expenditure in critically ill infants: study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Reyes Fernández Montes ◽  
Javier Urbano Villaescusa ◽  
Ángel Carrillo Álvarez ◽  
Ana Vivanco Allende ◽  
María José Solana García ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Energy Expenditure ◽  
Protein Content ◽  
Critically Ill ◽  
Nitrogen Balance ◽  
Controlled Trial ◽  
Serum Levels ◽  
Critically Ill Children ◽  
Protein Balance ◽  
Randomized Controlled

Abstract Background Nutritional support is essential in the care of critically ill children, since malnutrition in this population is associated to increased morbidity and mortality. Injury in patients admitted to pediatric intensive care units (PICU) results in a catabolic state, with augmented protein breakdown, leading to a negative protein balance. Current recommendations about protein prescription in PICU are fundamentally based on expert opinions, with a minimum threshold of 1.5 g/kg/day of protein, although protein needs could be higher in certain subgroups of patients. The main objective of the present study is to examine if the administration of a protein-enriched infant formula increases the serum levels of total proteins, albumin, prealbumin, transferrin, retinol, and improves nitrogen balance; and to analyze the effect of the high-protein diet on energy expenditure. A secondary objective is to register possible secondary effects of the protein-enriched diet. Methods a multicenter prospective randomized controlled trial (RCT) will be performed in three hospitals. Patients meeting inclusion criteria will be randomly allocated to one of three enteral feeding formula with different protein content. Blood and urine test, nitrogen balance assessment and energy expenditure testing by indirect calorimetry will be performed at the beginning of nutrition regimen and at 24 hours, 72 hours and 5-7 days after initiation. The sample size for this trial is estimated as 90 participants, with approximately 30 participants in each group. The data analysis will be by intention to treat. Discussion this RCT will provide new data about the amount of protein needed to improve levels of serum protein and nitrogen balance, surrogate of protein balance, in critically ill infants receiving enteral nutrition.

scholarly journals Comparison of the effect of three different protein content enteral diets on serum levels of proteins, nitrogen balance, and energy expenditure in critically ill infants: study protocol for a randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Reyes Fernández ◽  
Javier Urbano ◽  
Ángel Carrillo ◽  
Ana Vivanco ◽  
María José Solana ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Energy Expenditure ◽  
Critically Ill ◽  
Nitrogen Balance ◽  
Controlled Trial ◽  
High Protein Diet ◽  
Serum Levels ◽  
Critically Ill Children ◽  
Protein Balance ◽  
Randomized Controlled

Abstract Background Nutritional support is essential in the care of critically ill children since malnutrition in this population is associated with increased morbidity and mortality. Injury in patients admitted to pediatric intensive care units (PICU) results in a catabolic state and augmented protein breakdown, leading to a negative protein balance. Current recommendations about protein prescription in the PICU are fundamentally based on expert opinions, and the minimum threshold is 1.5 g/kg per day of protein, although protein needs could be higher in certain subgroups of patients. The main objectives of the present study are to examine whether the administration of a protein-enriched infant formula increases the serum levels of total proteins, albumin, prealbumin, transferrin, and retinol and improves nitrogen balance and to analyze the effect of the high-protein diet on energy expenditure. A secondary objective is to register possible secondary effects of the protein-enriched diet. Methods A multicenter prospective randomized controlled trial (RCT) will be performed in three hospitals. Patients meeting inclusion criteria will be randomly allocated to one of three enteral feeding formulae with different protein contents. Blood and urine test, nitrogen balance assessment, and energy expenditure testing by indirect calorimetry will be performed at the beginning of the nutrition regimen and at 24 h, 72 h and 5–7 days after initiation. The sample size for this trial is estimated to be 90 participants (about 30 participants in each group). The data analysis will be by intention to treat. Discussion This RCT will provide new data about the amount of protein needed to improve levels of serum protein and nitrogen balance, a surrogate of protein balance, in critically ill infants receiving enteral nutrition. Trial registration ClinicalTrials.gov identifier: NCT03901742. Registered April 1, 2019 – Retrospectively registered.

Gastric Feeding in Critically Ill Children: A Randomized Controlled Trial

2003 ◽  
Vol 12 (5) ◽  
pp. 461-468 ◽  
Author(s):  
Desley Horn ◽  
Wendy Chaboyer
Keyword(s):  
Randomized Controlled Trial ◽  
Intensive Care ◽  
Critically Ill ◽  
Controlled Trial ◽  
Pediatric Intensive Care ◽  
Critically Ill Children ◽  
Pharmacological Agents ◽  
Feeding Groups ◽  
Randomized Controlled ◽  
Gastric Feeding

• Background Provision of enteral nutrition via the gastric route is a common nursing procedure in pediatric intensive care units. Little research, however, has focused on children’s tolerance of different types of gastric feeding regimens. • Objectives To examine the relationship between 2 gastric feeding regimens, continuous and intermittent, and children’s tolerance as measured by the number of stools and prevalences of diarrhea and vomiting. • Methods A randomized controlled trial was conducted in an Australian pediatric intensive care unit; 45 children were randomly assigned to either the continuous or the intermittent gastric feeding groups. Participants remained in the assigned feeding group for the duration of the study, and values of variables used to monitor patients’ tolerance were recorded. • Results Both feeding groups were similar with respect to Pediatric Index Mortality score, age, weight, sex, diagnosis, and use of pharmacological agents known to affect the gastrointestinal tract. Additionally, the 2 groups did not differ in study duration or the daily volume of administered enteral formula per kilogram of body weight. The number of stools per day and the prevalences of diarrhea and vomiting did not differ significantly between the 2 groups. • Discussion Continuous and intermittent gastric feeding regimens have similar outcomes with respect to the number of stools per day and the prevalence of diarrhea and vomiting in pediatric intensive care patients. Further gastric feeding studies and the development of enteral feeding guidelines for critically ill children are needed.

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