Usefulness of Protein-enriched Infant Formula in Pediatric Intensive Care.
Effect of the Administration of an Enteral Milk Supplemented With Proteins to Infants Admitted in a Pediatric Intensive Care Unit
1 other identifier
interventional
90
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2016
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 28, 2016
CompletedFirst Submitted
Initial submission to the registry
March 25, 2019
CompletedFirst Posted
Study publicly available on registry
April 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedAugust 22, 2019
August 1, 2019
3.9 years
March 25, 2019
August 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Nitrogen balance variation
The variation of nitrogen balance (NB) from baseline to the study ending
From date of randomization until the date of first documented progression or date of discharge, whichever came first, assessed up to 7 days
Proportion of patients that meet study ending criteria
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 .
From date of randomization until the date of first documented progression or date of discharge, whichever came first, assessed up to 7 days
Secondary Outcomes (3)
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
Study Arms (3)
Standard Enteral Nutrition
ACTIVE COMPARATORStandard Enteral Nutrition: cow's milk based infant formula (Nidina, Nestlé, Barcelona, Spain).
Protein-enriched nutrition
ACTIVE COMPARATORProtein-enriched Enteral Nutrition: polymeric infant formula (Infatrini; Nutricia, Madrid, Spain)
High Protein-enriched Nutrition
ACTIVE COMPARATORHigh 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.
Interventions
Protein-enriched enteral nutrition with a polymeric infant formula
High protein-enriched enteral nutrition with a polymeric infant formula plus a protein supplement
Eligibility Criteria
You may qualify if:
- Children aged 1 month to 2 years.
- Children admitted to PICU.
- Children receiving enteral nutrition with an estimated length of over 72 hours.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Hospital Clínico Universitario de Santiago-CHUS
Santiago de Compostela, Galicia, 15706, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28007, Spain
Related Publications (1)
Fernandez R, Urbano J, Carrillo A, Vivanco A, Solana MJ, Rey C, Lopez-Herce J. 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 Oct 11;20(1):585. doi: 10.1186/s13063-019-3686-8.
PMID: 31604481DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Angel P Carrillo, PhD, MD
Hospital General Universitario Gregorio Marañón. Pediatric Intensive Care Unit.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2019
First Posted
April 3, 2019
Study Start
December 28, 2016
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
August 22, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- At the end of the study
All collected individual participant data (IPD)