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| ID | Type | Description | Link |
|---|---|---|---|
| 2U54MD000502 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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Despite evidence that both rapid weight gain and excessive body fat accrual are associated with overweight and obesity, usual neonatal care of preterm infants does not include assessment of body fat accrual. The study hypothesis is that identification of early changes in infant body composition (i.e. amount of fat mass and fat-free mass) reduces % body fat at 3 months of age.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 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). |
|
| Control Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assessment of infant body composition | Diagnostic Test | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Infant Body Composition | Percent body fat estimated by air displacement plethysmography | Assessed at 3 months of corrected age |
| Measure | Description | Time Frame |
|---|---|---|
| Growth | Weekly weight gain in grams | Birth to 3 months of corrected age |
| Length | Length in cm at 3 months of corrected age | 3 months of corrected age |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Intestinal Microbiome | Determined by molecular analyses of bacteria in fecal samples | Birth to 3 months of corrected age |
| Changes in Metabolic Pathways | Determined by molecular analyses of serum samples |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ariel A. Salas, MD, MSPH | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32634820 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Infant Body Composition | Percent body fat estimated by air displacement plethysmography | Posted | Mean | Standard Deviation | percentage of body fat | Assessed at 3 months of corrected age |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ariel Salas | University of Alabama at Birmingham | 205-934-4680 | asalas@peds.uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 14, 2018 | Mar 11, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D001835 | Body Weight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| Head Circumference | Head circumference in cm at 3 months of corrected age | 3 months of corrected age |
| Body Mass Index | 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 | Percent body fat estimated by air displacement plethysmography | Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first) |
| Birth to 3 months of corrected age |
| BG001 | 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) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | Weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| 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) |
|
|
| Secondary | Growth | Weekly weight gain in grams | Posted | Median | Inter-Quartile Range | grams/kg/day | Birth to 3 months of corrected age |
|
|
|
| Secondary | Length | Length in cm at 3 months of corrected age | 2 infants in the control group did not have a length measurement at 3 months of corrected age | Posted | Median | Inter-Quartile Range | cm | 3 months of corrected age |
|
|
|
| Secondary | Head Circumference | Head circumference in cm at 3 months of corrected age | Posted | Median | Inter-Quartile Range | cm | 3 months of corrected age |
|
|
|
| Secondary | Body Mass Index | Weight and height at 3 months of corrected age combined to report BMI in kg/m^2 | Posted | Median | Inter-Quartile Range | kg/m^2 | 3 months of corrected age |
|
|
|
| Secondary | Infant Body Composition | Percent body fat estimated by air displacement plethysmography | Posted | Mean | Standard Deviation | percentage of body fat | Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first) |
|
|
|
| Other Pre-specified | Changes in Intestinal Microbiome | Determined by molecular analyses of bacteria in fecal samples | Not Posted | Birth to 3 months of corrected age | Participants |
| Other Pre-specified | Changes in Metabolic Pathways | Determined by molecular analyses of serum samples | Not Posted | Birth to 3 months of corrected age | Participants |
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | 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) | 0 | 25 | 0 | 25 | 0 | 25 |
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| D000091642 | Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |