- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03575897
Serial Assessment of Body Fat Accrual in Very Preterm Infants
Serial Assessment of Body Fat Accrual in Very Preterm Infants: A Pilot Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Infants in the intervention group will have the information about infant body composition known to the clinicians caring for them (including reference data). Infants in the control group will also undergo serial measurements of infant body composition, but this information will not be available to the clinicians.
If parent agrees, stool "dirty" diapers will be collected 2 times (at the time of hospital discharge and at 3 months of corrected age).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
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Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Gestational age between 28 and 32 weeks of gestation
Exclusion Criteria:
- Gastrointestinal or neurologic malformations
- Terminal illness requiring limited or withheld support
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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).
|
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)
|
Active Comparator: 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.
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infant Body Composition
Time Frame: Assessed at 3 months of corrected age
|
Percent body fat estimated by air displacement plethysmography
|
Assessed at 3 months of corrected age
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Growth
Time Frame: Birth to 3 months of corrected age
|
Weekly weight gain in grams
|
Birth to 3 months of corrected age
|
Length
Time Frame: 3 months of corrected age
|
Length in cm at 3 months of corrected age
|
3 months of corrected age
|
Head Circumference
Time Frame: 3 months of corrected age
|
Head circumference in cm at 3 months of corrected age
|
3 months of corrected age
|
Body Mass Index
Time Frame: 3 months of corrected age
|
Weight and height at 3 months of corrected age combined to report BMI in kg/m^2
|
3 months of corrected age
|
Infant Body Composition
Time Frame: Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first)
|
Percent body fat estimated by air displacement plethysmography
|
Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Intestinal Microbiome
Time Frame: Birth to 3 months of corrected age
|
Determined by molecular analyses of bacteria in fecal samples
|
Birth to 3 months of corrected age
|
Changes in Metabolic Pathways
Time Frame: Birth to 3 months of corrected age
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Determined by molecular analyses of serum samples
|
Birth to 3 months of corrected age
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Collaborators and Investigators
Investigators
- Principal Investigator: Ariel A. Salas, MD, MSPH, University of Alabama at Birmingham
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 300001753
- 2U54MD000502 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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