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Energy Expenditure Assessment of Premature Infants

NCT00769509 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-08-28

No results posted yet for this study

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 will be carried out in which the newborn will be its own control. Randomization will be according to the type of diet at the beginning of the study. Half of the participants will be randomly assigned to begin the study using one type of milk (for example, human milk) and later another type of milk (preterm infant formula) and the other half will do the opposite.

Conditions

  • Weight

Interventions

OTHER

energy expenditure in preterm fed with preterm formula

Assessment of energy expenditure by indirect calorimetry in preterm infant fed with preterm formula 24 hours before measurements.

OTHER

assessment of energy expenditure

assessment of energy expenditure in preterm infant during fed with human milk with fortifier

Sponsors & Collaborators

  • Oswaldo Cruz Foundation

    lead OTHER

Principal Investigators

  • maria e moreira, MD · Oswaldo Cruz Foundation

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
3 Weeks
Max Age
5 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Brazil

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 NCT00769509 on ClinicalTrials.gov