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Growth and Body Composition in Preterm Infants (Crescer)

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ClinicalTrials.gov Identifier: NCT00875251
Recruitment Status : Recruiting
First Posted : April 3, 2009
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Maria Elisabeth Lopes Moreira, Oswaldo Cruz Foundation

Brief Summary:
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 or disease Intervention/treatment
Body Composition Device: body composition

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Growth and Body Composition of Very Low Birth Weight Infants Compared With Infants Birth at Term
Actual Study Start Date : April 1, 2009
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight

Group/Cohort Intervention/treatment
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




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


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



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

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


Contacts
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Contact: Maria E Moreira, MD; PhD 55-21-25541911 bebeth@iff.fiocruz.br
Contact: Dalva B Meio, MD; PhD 55-21-25541819 meio@centroin.com.br

Locations
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Brazil
Instituto Fernandes Figueira Enrolling by invitation
Rio de janeiro, RJ, Brazil, 22520-040
Maria Elisabeth L Moreira Recruiting
Rio de janeiro, Brazil, 22420040
Contact: Maria E Moreira, MD    552125132224    bebeth@iff.fiocruz.br   
Sub-Investigator: Dalva B Meio, MD         
Sponsors and Collaborators
Oswaldo Cruz Foundation
Investigators
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Principal Investigator: Maria E Moreira, MD Oswaldo Cruz Foundation

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Responsible Party: Maria Elisabeth Lopes Moreira, MD, PhD, Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier: NCT00875251    
Other Study ID Numbers: CAAE - 0292.0.008.000-05
First Posted: April 3, 2009    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Keywords provided by Maria Elisabeth Lopes Moreira, Oswaldo Cruz Foundation:
body composition
preterm infant
anthropometry