Energy Expenditure Assessment of Premature Infants

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
PAPES/Fiocruz
Information provided by:
Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier:
NCT00769509
First received: October 8, 2008
Last updated: October 11, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Weight Gain in Preterm Infants
Other: energy expenditure in preterm fed with preterm formula
Other: assessment of energy expenditure
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Official Title: Energy Expenditure Assessment of Preterm Infant With Very Low Birth Weight Fed With Human Milk or Preterm Formula

Resource links provided by NLM:


Further study details as provided by Oswaldo Cruz Foundation:

Primary Outcome Measures:
  • Energy expenditure adjusted by caloric density of milk in both groups measured by open system indirect calorimetry pre and pos feed With humam milk or preterm formula [ Time Frame: from 21 to 28 days of life ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • weight gain velocity [ Time Frame: 2 weeks before and after intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: March 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: preterm formula
Assessment of energy expenditure of preterm infant during fed with preterm formula
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 Name: energy expenditure
Active Comparator: human milk with fortifier
Assessment of energy expenditure by indirect calorimetry during fed with human milk with fortifier
Other: assessment of energy expenditure
assessment of energy expenditure in preterm infant during fed with human milk with fortifier
Other Name: energy expenditure

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 5 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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 Criteria:

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769509

Locations
Brazil
Oswaldo Cruz Foundation
Rio de janeiro, Brazil, 22250020
Sponsors and Collaborators
Oswaldo Cruz Foundation
PAPES/Fiocruz
Investigators
Principal Investigator: maria e moreira, MD Oswaldo Cruz Foundation
  More Information

No publications provided

Responsible Party: Maria Elisabeth Lopes Moreira, Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier: NCT00769509     History of Changes
Other Study ID Numbers: CAAE - 0057.0.008.000-06
Study First Received: October 8, 2008
Last Updated: October 11, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Oswaldo Cruz Foundation:
energy expenditure
indirect calorimetry
human milk
preterm formula
premature infant

Additional relevant MeSH terms:
Weight Gain
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014