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Serial Assessment of Body Fat Accrual in Very Preterm Infants

Primary Purpose

Infant,Premature, Body Weight, Adiposity

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Assessment of infant body composition
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infant,Premature focused on measuring Premature Infants, Body composition

Eligibility Criteria

1 Day - 14 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Gestational age between 28 and 32 weeks of gestation

Exclusion Criteria:

  • Gastrointestinal or neurologic malformations
  • Terminal illness requiring limited or withheld support

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control Group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Infant Body Composition
Percent body fat estimated by air displacement plethysmography

Secondary Outcome Measures

Growth
Weekly weight gain in grams
Length
Length in cm at 3 months of corrected age
Head Circumference
Head circumference in cm at 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
Infant Body Composition
Percent body fat estimated by air displacement plethysmography

Full Information

First Posted
June 21, 2018
Last Updated
December 13, 2022
Sponsor
University of Alabama at Birmingham
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03575897
Brief Title
Serial Assessment of Body Fat Accrual in Very Preterm Infants
Official Title
Serial Assessment of Body Fat Accrual in Very Preterm Infants: A Pilot Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
January 16, 2020 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant,Premature, Body Weight, Adiposity
Keywords
Premature Infants, Body composition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Assessment of infant body composition
Intervention Description
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)
Primary Outcome Measure Information:
Title
Infant Body Composition
Description
Percent body fat estimated by air displacement plethysmography
Time Frame
Assessed at 3 months of corrected age
Secondary Outcome Measure Information:
Title
Growth
Description
Weekly weight gain in grams
Time Frame
Birth to 3 months of corrected age
Title
Length
Description
Length in cm at 3 months of corrected age
Time Frame
3 months of corrected age
Title
Head Circumference
Description
Head circumference in cm at 3 months of corrected age
Time Frame
3 months of corrected age
Title
Body Mass Index
Description
Weight and height at 3 months of corrected age combined to report BMI in kg/m^2
Time Frame
3 months of corrected age
Title
Infant Body Composition
Description
Percent body fat estimated by air displacement plethysmography
Time Frame
Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first)
Other Pre-specified Outcome Measures:
Title
Changes in Intestinal Microbiome
Description
Determined by molecular analyses of bacteria in fecal samples
Time Frame
Birth to 3 months of corrected age
Title
Changes in Metabolic Pathways
Description
Determined by molecular analyses of serum samples
Time Frame
Birth to 3 months of corrected age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariel A. Salas, MD, MSPH
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32634820
Citation
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.
Results Reference
result

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Serial Assessment of Body Fat Accrual in Very Preterm Infants

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