Serial Assessment of Body Fat Accrual in Very Preterm Infants

December 5, 2023 updated by: Ariel A. Salas, University of Alabama at Birmingham

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

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.

Study Overview

Status

Active, not recruiting

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

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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).
Diagnostic test: 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)
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.
Diagnostic test: 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)

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
Determined by molecular analyses of serum samples
Birth to 3 months of corrected age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Ariel A. Salas, MD, MSPH, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2018

Primary Completion (Actual)

January 16, 2020

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 21, 2018

First Submitted That Met QC Criteria

June 29, 2018

First Posted (Actual)

July 3, 2018

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

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

No

Studies a U.S. FDA-regulated device product

Yes

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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