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

NCT03901742 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2019-08-22

No results posted yet for this study

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.

Conditions

  • Protein-Energy Malnutrition

Interventions

OTHER

Protein-enriched nutrition

Protein-enriched enteral nutrition with a polymeric infant formula

DIETARY_SUPPLEMENT

High Protein-enriched Nutrition

High protein-enriched enteral nutrition with a polymeric infant formula plus a protein supplement

OTHER

Standard Enteral Nutrition

Cow's milk based infant formula.

Sponsors & Collaborators

  • Maternal, Neonatal and Child Health Research Network

    collaborator OTHER

  • European Regional Development Fund

    collaborator OTHER

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Hospital General Universitario Gregorio Marañon

    lead OTHER

Principal Investigators

  • Angel P Carrillo, PhD, MD · Hospital General Universitario Gregorio Marañón. Pediatric Intensive Care Unit.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-28
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03901742 on ClinicalTrials.gov