NCT03575897

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Sep 2018Dec 2026

First Submitted

Initial submission to the registry

June 21, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 3, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 10, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2020

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

May 17, 2021

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

June 21, 2018

Results QC Date

February 13, 2021

Last Update Submit

March 9, 2026

Conditions

Infant,PrematureBody WeightAdiposity

Keywords

Premature InfantsBody composition

Outcome Measures

Primary Outcomes (1)

  • Infant Body Composition

    Percent body fat estimated by air displacement plethysmography

    Assessed at 3 months of corrected age

Secondary Outcomes (5)

  • Growth

    Birth to 3 months of corrected age

  • Length

    3 months of corrected age

  • Head Circumference

    3 months of corrected age

  • Body Mass Index

    3 months of corrected age

  • Infant Body Composition

    Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first)

Other Outcomes (2)

  • Changes in Intestinal Microbiome

    Birth to 3 months of corrected age

  • Changes in Metabolic Pathways

    Birth to 3 months of corrected age

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Assessment of infant body compositionDIAGNOSTIC_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)

Control GroupIntervention Group

Eligibility Criteria

Age1 Day - 14 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Gestational age between 28 and 32 weeks of gestation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

  • 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.

    PMID: 32634820RESULT

MeSH Terms

Conditions

Premature BirthBody WeightObesity

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Results Point of Contact

Title
Dr. Ariel Salas
Organization
University of Alabama at Birmingham
asalas@peds.uab.edu
205-934-4680

Study Officials

  • Ariel A. Salas, MD, MSPH

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 21, 2018

First Posted

July 3, 2018

Study Start

September 10, 2018

Primary Completion

January 16, 2020

Study Completion (Estimated)

December 1, 2026

Last Updated

March 23, 2026

Results First Posted

May 17, 2021

Record last verified: 2026-03

Locations

US(1)