Adiposity, Body Weight, Infant,Premature
Conditions
Keywords
Premature Infants, Body composition
Brief summary
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.
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).
Interventions
DIAGNOSTIC_TESTAssessment 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)
Sponsors
University of Alabama at Birmingham
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 14 Days
Healthy volunteers
No
Inclusion criteria
* Gestational age between 28 and 32 weeks of gestation
Exclusion criteria
* Gastrointestinal or neurologic malformations * Terminal illness requiring limited or withheld support
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant Body Composition | Assessed at 3 months of corrected age | Percent body fat estimated by air displacement plethysmography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Growth | Birth to 3 months of corrected age | Weekly weight gain in grams |
| Length | 3 months of corrected age | Length in cm at 3 months of corrected age |
| Head Circumference | 3 months of corrected age | Head circumference in cm at 3 months of corrected age |
| Body Mass Index | 3 months of corrected age | Weight and height at 3 months of corrected age combined to report BMI in kg/m\^2 |
| Infant Body Composition | Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first) | Percent body fat estimated by air displacement plethysmography |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAriel A. Salas, MD, MSPH
University of Alabama at Birmingham
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 25 |
| 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) | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Intervention Group | Total | Control Group |
|---|---|---|---|
| Age, Categorical <=18 years | 25 Participants | 50 Participants | 25 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 31 Weeks | 30 Weeks | 30 Weeks |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 23 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 27 Participants | 13 Participants |
| Region of Enrollment United States | 25 Participants | 50 Participants | 25 Participants |
| Sex: Female, Male Female | 10 Participants | 24 Participants | 14 Participants |
| Sex: Female, Male Male | 15 Participants | 26 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Infant Body Composition
Percent body fat estimated by air displacement plethysmography
Time frame: Assessed at 3 months of corrected age
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Infant Body Composition | 21 percentage of body fat | Standard Deviation 4 |
| Control Group | Infant Body Composition | 19 percentage of body fat | Standard Deviation 6 |
Secondary
Body Mass Index
Weight and height at 3 months of corrected age combined to report BMI in kg/m\^2
Time frame: 3 months of corrected age
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group | Body Mass Index | 5 kg/m^2 |
| Control Group | Body Mass Index | 6 kg/m^2 |
Secondary
Growth
Weekly weight gain in grams
Time frame: Birth to 3 months of corrected age
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group | Growth | 8 grams/kg/day |
| Control Group | Growth | 9 grams/kg/day |
Secondary
Head Circumference
Head circumference in cm at 3 months of corrected age
Time frame: 3 months of corrected age
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group | Head Circumference | 40 cm |
| Control Group | Head Circumference | 41 cm |
Secondary
Infant Body Composition
Percent body fat estimated by air displacement plethysmography
Time frame: Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Infant Body Composition | 14 percentage of body fat | Standard Deviation 5 |
| Control Group | Infant Body Composition | 14 percentage of body fat | Standard Deviation 3 |
Secondary
Length
Length in cm at 3 months of corrected age
Time frame: 3 months of corrected age
Population: 2 infants in the control group did not have a length measurement at 3 months of corrected age
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group | Length | 59 cm |
| Control Group | Length | 60 cm |
Other Pre-specified
Changes in Intestinal Microbiome
Determined by molecular analyses of bacteria in fecal samples
Time frame: Birth to 3 months of corrected age
Other Pre-specified
Changes in Metabolic Pathways
Determined by molecular analyses of serum samples
Time frame: Birth to 3 months of corrected age