Serial Assessment of Body Fat Accrual in Very Preterm Infants

Study Overview
=================
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).

Official Title
-----------------
Serial Assessment of Body Fat Accrual in Very Preterm Infants: A Pilot Randomized Trial

Conditions
-----------------
Adiposity, Infant,Premature, Body Weight

Intervention / Treatment
-----------------
* Diagnostic Test: Assessment of infant body composition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age between 28 and 32 weeks of gestation Exclusion Criteria: Gastrointestinal or neurologic malformations Terminal illness requiring limited or withheld support

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 14 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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). | Diagnostic Test: Assessment of infant body composition<br>* 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)<br>|
| Active Comparator: Control Group<br>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. | Diagnostic Test: Assessment of infant body composition<br>* 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)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant Body Composition | 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 | 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 | 
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premature Infants, Body composition