Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 38406 for:    body
Previous Study | Return to List | Next Study

Serial Assessment of Body Fat Accrual in Very Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Infant,Premature Body Weight Adiposity Diagnostic Test: Assessment of infant body composition Not Applicable

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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Serial Assessment of Body Fat Accrual in Very Preterm Infants: A Pilot Randomized Trial
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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)




Primary Outcome Measures :
  1. Infant body composition [ Time Frame: Assessed at 3 months of corrected age ]
    Percent body fat estimated by air displacement plethysmography


Secondary Outcome Measures :
  1. Growth [ Time Frame: Birth to 3 months of corrected age ]
    Weekly weight gain in grams

  2. Length [ Time Frame: Birth to 3 months of corrected age ]
    Weekly length in cm

  3. Head circumference [ Time Frame: Birth to 3 months of corrected age ]
    Weekly head circumference in cm

  4. 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

  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575897


Contacts
Layout table for location contacts
Contact: Ariel A. Salas, MD, MSPH 205-934-4680 asalas@peds.uab.edu

Locations
Layout table for location information
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Ariel A. Salas, MD, MSPH         
Sponsors and Collaborators
University of Alabama at Birmingham
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
Layout table for investigator information
Principal Investigator: Ariel A. Salas, MD, MSPH University of Alabama at Birmingham

Layout table for additonal information
Responsible Party: Ariel A. Salas, MD, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03575897     History of Changes
Other Study ID Numbers: 300001753
2U54MD000502 ( U.S. NIH Grant/Contract )
First Posted: July 3, 2018    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018

Layout table for additional information
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

Keywords provided by Ariel A. Salas, MD, University of Alabama at Birmingham:
Premature Infants
Body composition

Additional relevant MeSH terms:
Layout table for MeSH terms
Body Weight
Signs and Symptoms