Growth and Body Composition in Preterm Infants (Crescer)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Oswaldo Cruz Foundation
Sponsor:
Information provided by (Responsible Party):
Maria Elisabeth Lopes Moreira, Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier:
NCT00875251
First received: April 2, 2009
Last updated: July 21, 2015
Last verified: July 2015
  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: Measurements of 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 Oswaldo Cruz Foundation:

Primary Outcome Measures:
  • z-score weight to age [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    weiggt gain from birth to 12 months of age

  • body composition [ Time Frame: from discharge to 3 months of chronological age ] [ Designated as safety issue: No ]
    fat mass and fat free mass from PEA BOD


Secondary Outcome Measures:
  • anthropometry [ Time Frame: from term to first year of life ] [ Designated as safety issue: No ]
    Anthropometry assesment : weight, lenght, head circunference, skinfold thikness, BMI


Estimated Enrollment: 60
Study Start Date: April 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
term infants
Term infants from 2 days of life to 7 days of life without IUGR
Device: Measurements of body composition
Measurements of body composition using 3 different devices: Measurements of body composition using DXA using iDXA- General Electric, Bioimpedance measurements will be made with the RJL System (Quantum BIA 101Q equipment) and the Hydra multi-frequency equipment (Xitron technologies), air-displacement plethysmography in the PEA POD System (Life Measurement).
Other Names:
  • bone densitometry (iDXA-GE), Bioelectric impedance (Hydra from Xitron technologies)and and
  • air displacement plethysmography by Pea Pod System (Life Measurement)
preterm infants
very low birth weight infants before discharge
Device: Measurements of body composition
Measurements of body composition using 3 different devices: Measurements of body composition using DXA using iDXA- General Electric, Bioimpedance measurements will be made with the RJL System (Quantum BIA 101Q equipment) and the Hydra multi-frequency equipment (Xitron technologies), air-displacement plethysmography in the PEA POD System (Life Measurement).
Other Names:
  • bone densitometry (iDXA-GE), Bioelectric impedance (Hydra from Xitron technologies)and and
  • air displacement plethysmography by Pea Pod System (Life Measurement)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
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
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: NCT00875251

Contacts
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
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
Principal Investigator: Maria E Moreira, MD Oswaldo Cruz Foundation
  More Information

No publications provided

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
Study First Received: April 2, 2009
Last Updated: July 21, 2015
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Oswaldo Cruz Foundation:
body composition
preterm infant
anthropometry

ClinicalTrials.gov processed this record on August 02, 2015