Serial Assessment of Body Fat Accrual in Very Preterm Infants
NCT ID: NCT03575897
Last Updated: 2025-03-19
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
50 participants
INTERVENTIONAL
2018-09-10
2025-12-31
Brief Summary
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Detailed Description
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If parent agrees, stool "dirty" diapers will be collected 2 times (at the time of hospital discharge and at 3 months of corrected age).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention Group
Infants randomly assigned to the intervention group will undergo serial measurements of infant body composition during their hospitalization. This information about infant body composition will be known to the clinicians caring for them (including reference data).
Assessment of infant body composition
Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)
Control Group
Infants randomly assigned to the control group will also undergo serial measurements of infant body composition during their hospitalization, but this information will not be available to the clinicians caring for them.
Assessment of infant body composition
Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)
Interventions
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Assessment of infant body composition
Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Terminal illness requiring limited or withheld support
1 Day
14 Days
ALL
No
Sponsors
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National Institute on Minority Health and Health Disparities (NIMHD)
NIH
University of Alabama at Birmingham
OTHER
Responsible Party
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Ariel A. Salas
Assistant Professor
Principal Investigators
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Ariel A. Salas, MD, MSPH
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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References
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Salas AA, Jerome ML, Chandler-Laney P, Ambalavanan N, Carlo WA. Serial assessment of fat and fat-free mass accretion in very preterm infants: a randomized trial. Pediatr Res. 2020 Nov;88(5):733-738. doi: 10.1038/s41390-020-1052-x. Epub 2020 Jul 7.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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300001753
Identifier Type: -
Identifier Source: org_study_id
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