Status:

COMPLETED

Energy Expenditure Assessment of Premature Infants

Lead Sponsor:

Oswaldo Cruz Foundation

Conditions:

Weight

Eligibility:

All Genders

3-5 years

Phase:

PHASE4

Brief Summary

The goal of this study is verify if the energy expenditure in preterm infant fed with human milk is different from preterm formula. A randomized, controlled, crossover, double blind clinical trial wil...

Detailed Description

Post-natal growth restriction has become a problem yet to be solved and studied in most neonatal units. Newborns with very low birth weight grow at a rate lower than expected, thus culminating with de...

Eligibility Criteria

Inclusion

  • Premature infant admitted to the Intensive Care Unit of Fernandes Figueira Institute with birth weight under 1500g, adequate for their gestational age, clinically stable, without congenital malformations, nor genetic syndromes confirmed by the geneticist, nor congenital infections confirmed by the physician and lab tests will be eligible for this study, as well as newborn infants who developed intra-ventricular hemorrhage (grades III and IV).

Exclusion

  • Premature infant that present the following in their exams shall be excluded: significant gastric residue, signs and symptoms of sepsis, repeated apnea events which required the use of respiratory stimulants.

Key Trial Info

Start Date :

March 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2015

Estimated Enrollment :

25 Patients enrolled

Trial Details

Trial ID

NCT00769509

Start Date

March 1 2009

End Date

March 1 2015

Last Update

August 28 2019

Active Locations (1)

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Oswaldo Cruz Foundation

Rio de Janeiro, Brazil, 22250020