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Growth and Body Composition in Preterm Infants (Crescer)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00875251
First Posted: April 3, 2009
Last Update Posted: August 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maria Elisabeth Lopes Moreira, Oswaldo Cruz Foundation
  Purpose
Growth is traditionally used as a prognostic measure after admission to a neonatal intensive care unit (NICU). Quality of neonatal intensive care is one of the factors determining the health and quality of life for those that survive, with the principal objective of increasing disability-free survival. Nowadays, there is some researches showing us that these preterm babies present a different body composition when they achieve term age compared with babies birth at term and this condition could be putting these babies in risk to metabolic syndrome early in adult age. The majority of infants born between 24 and 29 weeks of gestational age fail to achieve the mean birth weight for fetuses of the same gestational age, and many weigh below the 10th percentile at hospital discharge. The focus of this study is the growth and body composition of very low birth weight infants growing in the extrauterine environment. The central question is, when they reach the corresponding term weight, is the body composition of newborns growing outside of the uterus different from that of infants growing in the intrauterine environment? The investigators are also trying to validate 3 different methods to research body composition: DXA, air-displacement plethysmography and electric bioimpedance.

Condition Intervention
Body Composition Device: body composition

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Growth and Body Composition of Very Low Birth Weight Infants Compared With Infants Birth at Term

Resource links provided by NLM:


Further study details as provided by Maria Elisabeth Lopes Moreira, Oswaldo Cruz Foundation:

Primary Outcome Measures:
  • body composition [ Time Frame: from discharge to 3 months of chronological age ]
    fat mass and fat free mass from PEA BOD


Secondary Outcome Measures:
  • anthropometry [ Time Frame: from term to first year of life ]
    Anthropometry assesment : weight, lenght, head circunference, skinfold thikness, BMI


Estimated Enrollment: 60
Actual Study Start Date: April 1, 2009
Estimated Study Completion Date: November 30, 2017
Primary Completion Date: January 31, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
term infants body composition
Term infants from 2 days of life to 7 days of life without IUGR
Device: body composition
Measurements of body composition using 2 differents devices: Bioimpedance measurements will be made with the RJL System (Quantum BIA 101Q equipment) air-displacement plethysmography in the PEA POD System (Life Measurement).
Other Name: air displacement plethysmography
preterm infants body composition
very low birth weight infants before discharge
Device: body composition
Measurements of body composition using 2 differents devices: Bioimpedance measurements will be made with the RJL System (Quantum BIA 101Q equipment) air-displacement plethysmography in the PEA POD System (Life Measurement).
Other Name: air displacement plethysmography

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Preterm infants with birth weight less than 1500g

Term infants without IUGR

Criteria

Inclusion Criteria:

  • appropriate for gestational age (AGA) and small for gestational age (SGA) premature newborns with gestational age less than or equal to 32 weeks and less than 1500g at birth
  • AGA term newborns with gestational age greater than or equal to 37 weeks and less than 42 weeks and with no history of maternal disease that might compromise intrauterine growth

Exclusion Criteria:

  • congenital malformations
  • genetic syndromes confirmed by the geneticist
  • clinically and laboratory-confirmed congenital infections
  • children of mothers with the human immunodeficiency virus (HIV)
  • children of diabetic mothers
  • newborns that develop severe intraventricular hemorrhage or necrotizing enterocolitis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00875251


Locations
Brazil
Instituto Fernandes Figueira
Rio de janeiro, RJ, Brazil, 22520-040
Maria Elisabeth L Moreira
Rio de janeiro, Brazil, 22420040
Sponsors and Collaborators
Oswaldo Cruz Foundation
Investigators
Principal Investigator: Maria E Moreira, MD Oswaldo Cruz Foundation
  More Information

Responsible Party: Maria Elisabeth Lopes Moreira, MD, PhD, Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier: NCT00875251     History of Changes
Other Study ID Numbers: CAAE - 0292.0.008.000-05
First Submitted: April 2, 2009
First Posted: April 3, 2009
Last Update Posted: August 17, 2017
Last Verified: August 2017

Keywords provided by Maria Elisabeth Lopes Moreira, Oswaldo Cruz Foundation:
body composition
preterm infant
anthropometry