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Serial Assessment of Body Fat Accrual in Very Preterm Infants

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ClinicalTrials.gov Identifier: NCT03575897
Recruitment Status : Recruiting
First Posted : July 3, 2018
Last Update Posted : October 26, 2018
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Ariel A. Salas, MD, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE June 21, 2018
First Posted Date  ICMJE July 3, 2018
Last Update Posted Date October 26, 2018
Actual Study Start Date  ICMJE September 10, 2018
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2018)
Infant body composition [ Time Frame: Assessed at 3 months of corrected age ]
Percent body fat estimated by air displacement plethysmography
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03575897 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2018)
  • Growth [ Time Frame: Birth to 3 months of corrected age ]
    Weekly weight gain in grams
  • Length [ Time Frame: Birth to 3 months of corrected age ]
    Weekly length in cm
  • Head circumference [ Time Frame: Birth to 3 months of corrected age ]
    Weekly head circumference in cm
  • Body mass index [ Time Frame: Birth to 3 months of corrected age ]
    Weight and height will be combined to report BMI in kg/m^2
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 29, 2018)
  • Changes in intestinal microbiome [ Time Frame: Birth to 3 months of corrected age ]
    Determined by molecular analyses of bacteria in fecal samples
  • Changes in metabolic pathways [ Time Frame: Birth to 3 months of corrected age ]
    Determined by molecular analyses of serum samples
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Serial Assessment of Body Fat Accrual in Very Preterm Infants
Official Title  ICMJE Serial Assessment of Body Fat Accrual in Very Preterm Infants: A Pilot Randomized Trial
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Infant,Premature
  • Body Weight
  • Adiposity
Intervention  ICMJE 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)
Study Arms  ICMJE
  • 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).
    Intervention: Diagnostic Test: Assessment of infant body composition
  • 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.
    Intervention: Diagnostic Test: Assessment of infant body composition
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 29, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2019
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Gestational age between 28 and 32 weeks of gestation

Exclusion Criteria:

  • Gastrointestinal or neurologic malformations
  • Terminal illness requiring limited or withheld support
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 14 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ariel A. Salas, MD, MSPH 205-934-4680 asalas@peds.uab.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03575897
Other Study ID Numbers  ICMJE 300001753
2U54MD000502 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ariel A. Salas, MD, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE National Institute on Minority Health and Health Disparities (NIMHD)
Investigators  ICMJE
Principal Investigator: Ariel A. Salas, MD, MSPH University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP