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NCT Number: NCT03575897

Serial Assessment of Body Fat Accrual in Very Preterm Infants

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.

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Key information

Conditions

Infant,Premature Adiposity Body Weight Female Urogenital Diseases and Pregnancy Complications Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obstetric Labor Complications Obstetric Labor, Premature Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Signs and Symptoms Urogenital Diseases

Age range

1 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gestational age between 28 and 32 weeks of gestation

Exclusion criteria

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

Treatment and study plan

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)

Primary outcomes

  1. Infant Body Composition

    Time frame: Assessed at 3 months of corrected age

    Percent body fat estimated by air displacement plethysmography

Secondary outcomes

  1. Growth

    Time frame: Birth to 3 months of corrected age

    Weekly weight gain in grams

  2. Length

    Time frame: 3 months of corrected age

    Length in cm at 3 months of corrected age

  3. Head Circumference

    Time frame: 3 months of corrected age

    Head circumference in cm at 3 months of corrected age

  4. 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

  5. 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

Other outcomes

  1. Changes in Intestinal Microbiome

    Time frame: Birth to 3 months of corrected age

    Determined by molecular analyses of bacteria in fecal samples

  2. Changes in Metabolic Pathways

    Time frame: Birth to 3 months of corrected age

    Determined by molecular analyses of serum samples

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2026
First posted
Jul 3, 2018
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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