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Usefulness of Protein-enriched Infant Formula in Pediatric Intensive Care.

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ClinicalTrials.gov Identifier: NCT03901742
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : April 3, 2019
Sponsor:
Collaborators:
Maternal, Neonatal and Child Health Research Network
European Regional Development Fund
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Hospital General Universitario Gregorio Marañon

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.

Condition or disease Intervention/treatment Phase
Protein-Energy Malnutrition Other: Protein-enriched nutrition Dietary Supplement: High Protein-enriched Nutrition Other: Standard Enteral Nutrition Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of the Administration of an Enteral Milk Supplemented With Proteins to Infants Admitted in a Pediatric Intensive Care Unit
Actual Study Start Date : December 28, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard Enteral Nutrition
Standard Enteral Nutrition: cow's milk based infant formula (Nidina, Nestlé, Barcelona, Spain).
Other: Standard Enteral Nutrition
Cow's milk based infant formula.

Active Comparator: Protein-enriched nutrition
Protein-enriched Enteral Nutrition: polymeric infant formula (Infatrini; Nutricia, Madrid, Spain)
Other: Protein-enriched nutrition
Protein-enriched enteral nutrition with a polymeric infant formula

Active Comparator: 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.
Dietary Supplement: High Protein-enriched Nutrition
High protein-enriched enteral nutrition with a polymeric infant formula plus a protein supplement




Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. variation of plasma protein levels [ 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 ]
    variation of plasma protein levels (mg/dL) (total proteins, albumin, prealbumin, transferrin and retinol-binding protein)

  2. variation of resting energy expenditure [ 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 ]
    variation of resting energy expenditure measured with indirect calorimetry during the study period.

  3. the incidence of gastrointestinal complications [ 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 ]
    Gastrointestinal complications: abdominal distension, vomiting, diarrhea and excessive gastric residue



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Ages Eligible for Study:   1 Month to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Children aged 1 month to 2 years.
  2. Children admitted to PICU.
  3. 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:

  1. Age less than 1 month or over 2 years.
  2. Diabetes mellitus or any inborn metabolic error.
  3. Parenteral nutrition.
  4. Bicarbonate infusion.
  5. Renal replacement therapy.
  6. Children receiving exclusive breastfeeding or in a need of special enteral formula.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03901742


Contacts
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Contact: Javier Urbano, PhD, MD +34915290328 javierurbanovillaescusa@gmail.com
Contact: Jesús López-Herce, PhD, MD +34915290328 pielvi@hotmail.com

Locations
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Spain
Hospital Universitario Central de Asturias Recruiting
Oviedo, Asturias, Spain, 33011
Contact: Corsino Rey, PhD, MD    +34985108000    crey@uniovi.es   
Sub-Investigator: Reyes Fernández, MD         
Principal Investigator: Corsino Rey, PhD, MD         
Hospital Clínico Universitario de Santiago-CHUS Recruiting
Santiago De Compostela, Galicia, Spain, 15706
Contact: Antonio Rodriguez, PhD, MD    +34 606796362    Antonio.Rodriguez.Nunez@sergas.es   
Principal Investigator: Antonio Rodriguez, PhD, MD         
Hospital General Universitario Gregorio Marañón Recruiting
Madrid, Spain, 28007
Contact: Javier Urbano, PhD, MD    +34915290328    javierurbanovillaescusa@gmail.com   
Contact: Jesús López-Herce, PhD, MD    +34915290328    pielvi@hotmail.com   
Principal Investigator: Angel P Carrillo, PhD, MD         
Sub-Investigator: Jesus López-Herce, PhD, MD         
Sub-Investigator: Javier Urbano, PhD, MD         
Sponsors and Collaborators
Hospital General Universitario Gregorio Marañon
Maternal, Neonatal and Child Health Research Network
European Regional Development Fund
Instituto de Salud Carlos III
Investigators
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Principal Investigator: Angel P Carrillo, PhD, MD Hospital General Universitario Gregorio Marañón. Pediatric Intensive Care Unit.

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Responsible Party: Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier: NCT03901742     History of Changes
Other Study ID Numbers: FIBHGM-ECNC011-2010
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected individual participant data (IPD)
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: At the end of the study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital General Universitario Gregorio Marañon:
Children
Intensive Care
Nutrition
Enteral feeding
Protein intake
Protein balance.
Lean Body Mass

Additional relevant MeSH terms:
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Malnutrition
Protein-Energy Malnutrition
Nutrition Disorders
Protein Deficiency
Deficiency Diseases