Effect of the Administration of an Enteral Milk Supplemented With Proteins to Infants Admitted in a Pediatric Intensive Care Unit
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 90
- Locations
- 3
- Primary Endpoint
- Nitrogen balance variation
Study Overview
Brief Summary
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. 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.
Detailed Description
Background Protein-caloric malnutrition, with an incidence of 15-20 %, is the most important type of malnutrition in Pediatric Intensive Care Units (PICU). It is associated to poor outcomes in critically ill children: malnourished patients present an increased physiologic instability and quantity of care, with higher duration of mechanic ventilation and length of stay and increased mortality.
Current recommendations about protein prescription in critically ill children are fundamentally based on expert opinions, since studies on protein supplementation are scarce, with small sample sizes and heterogeneous patient populations, doses of protein and route of administration.
Study design Once an eligible patient is admitted to PICU, written informed consent will be requested from parents or legal representative of the child by the physician responsible of the patient. They will be made aware that participation is voluntary, and they will be allowed to refuse further participation in the trial whenever they want.
After enrolment, the patient will be allocated randomly, in order of recruitment, into one of the three 3 diet groups using a randomized data table generated with Epidat 3.1 software. A copy of the randomization list will be securely stored in an envelope located at PICU working area desk drawer, which will be opened after the patient enrolment on the study. Physicians, care givers and investigators will know the allocation prior to the start of enteral feeding.
All patients will receive exclusively enteral nutrition via nasogastric o transpyloric tube.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 1 Month to 2 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children aged 1 month to 2 years.
- •Children admitted to PICU.
- •Children receiving enteral nutrition with an estimated length of over 72 hours.
Exclusion Criteria
- •Children who met any of the following criteria will be excluded:
- •Age less than 1 month or over 2 years.
- •Diabetes mellitus or any inborn metabolic error.
- •Parenteral nutrition.
- •Bicarbonate infusion.
- •Renal replacement therapy.
- •Children receiving exclusive breastfeeding or in a need of special enteral formula.
Arms & Interventions
Standard Enteral Nutrition
Standard Enteral Nutrition: cow's milk based infant formula (Nidina, Nestlé, Barcelona, Spain).
Intervention: Standard Enteral Nutrition (Other)
Protein-enriched nutrition
Protein-enriched Enteral Nutrition: polymeric infant formula (Infatrini; Nutricia, Madrid, Spain)
Intervention: Protein-enriched nutrition (Other)
High Protein-enriched Nutrition
High Protein-enriched Enteral Nutrition: polymeric infant formula (Infatrini; Nutricia, Madrid, Spain) supplemented with 2.6 g of protein/100 mL of formula. The source of the protein supplement would be a nonhydrolyzed protein cow's milk-based formula (Resource Protein Instant; Nestlé, Barcelona, Spain). Final composition 5.1 g/100 mL.
Intervention: High Protein-enriched Nutrition (Dietary Supplement)
Outcomes
Primary Outcomes
Nitrogen balance variation
Time Frame: From date of randomization until the date of first documented progression or date of discharge, whichever came first, assessed up to 7 days
The variation of nitrogen balance (NB) from baseline to the study ending
Proportion of patients that meet study ending criteria
Time Frame: From date of randomization until the date of first documented progression or date of discharge, whichever came first, assessed up to 7 days
Study ending criteria: serum urea levels elevates higher than 80 mg/dL without evidence of renal function disturbance or hypercatabolism; hyperproteinemia higher than 8.5 g/dL .
Secondary Outcomes
- variation of plasma protein levels(From date of randomization until the date of first documented progression or date of discharge, whichever came first, assessed up to 7 days)
- variation of resting energy expenditure(From date of randomization until the date of first documented progression or date of discharge, whichever came first, assessed up to 7 days)
- the incidence of gastrointestinal complications(From date of randomization until the date of first documented progression or date of discharge, whichever came first, assessed up to 7 days)