Growth and Body Composition in Preterm Infants
Crescer
Growth and Body Composition of Very Low Birth Weight Infants Compared With Infants Birth at Term
1 other identifier
observational
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2009
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 2, 2009
CompletedFirst Posted
Study publicly available on registry
April 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedSeptember 18, 2020
September 1, 2020
12.8 years
April 2, 2009
September 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
body composition
fat mass and fat free mass from PEA BOD
from discharge to 3 months of chronological age
Secondary Outcomes (1)
anthropometry
from term to first year of life
Study Arms (2)
term infants body composition
Term infants from 2 days of life to 7 days of life without IUGR
preterm infants body composition
very low birth weight infants before discharge
Interventions
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).
Eligibility Criteria
Preterm infants with birth weight less than 1500g Term infants without IUGR
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Instituto Fernandes Figueira
Rio de Janeiro, Rio de Janeiro, 22520-040, Brazil
Maria Elisabeth L Moreira
Rio de Janeiro, 22420040, Brazil
Related Publications (1)
Nehab SR, Villela LD, Soares FVM, Abranches AD, Araujo DMR, da Silva LML, Amaral YNV, Junior SCG, Meio MDBB, Moreira ME. Gestational weight gain and body composition of full-term newborns and infants: a cohort study. BMC Pregnancy Childbirth. 2020 Aug 20;20(1):474. doi: 10.1186/s12884-020-03145-x.
PMID: 32819310DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria E Moreira, MD
Oswaldo Cruz Foundation
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
April 2, 2009
First Posted
April 3, 2009
Study Start
April 1, 2009
Primary Completion
December 30, 2021
Study Completion
December 30, 2021
Last Updated
September 18, 2020
Record last verified: 2020-09