Energy Expenditure Assessment of Premature Infants

NCT00769509 | Completed Phase 4 DMC

• 1 other identifier: CAAE - 0057.0.008.000-06
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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 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

Keywords

energy expenditure; indirect calorimetry; human milk; preterm formula; premature infant

Outcome Measures

Primary Outcomes (1)

• 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

  from 21 to 28 days of life

Secondary Outcomes (1)

• weight gain velocity

  2 weeks before and after intervention

Study Arms (2)

preterm formula

EXPERIMENTAL

Assessment of energy expenditure of preterm infant during fed with preterm formula

Other: energy expenditure in preterm fed with preterm formula

human milk with fortifier

ACTIVE COMPARATOR

Assessment of energy expenditure by indirect calorimetry during fed with human milk with fortifier

Other: assessment of energy expenditure

Interventions

energy expenditure in preterm fed with preterm formula OTHER

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

Also known as: energy expenditure

preterm formula

assessment of energy expenditure OTHER

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

Also known as: energy expenditure

human milk with fortifier

Eligibility Criteria

• Age: 3 Weeks - 5 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oswaldo Cruz Foundation: lead

Study Sites (1)

Oswaldo Cruz Foundation

Rio de Janeiro, 22250020, Brazil

Location

MeSH Terms

Conditions

Body Weight; Premature Birth

Interventions

Energy Metabolism

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Metabolism

Study Officials

• maria e moreira, MD

  Oswaldo Cruz Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 9, 2008
• Study Start: March 1, 2009
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

BR (1)