Serial Assessment of Body Fat Accrual in Very Preterm Infants

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03575897
• Collaborator: National Institute on Minority Health and Health Disparities (NIMHD) (NIH)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 50.7
• Patients Per Site Per Month: 1

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Actual 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: Sep 10, 2018
• Actual Primary Completion Date: Jan 16, 2020
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Infant Body Composition [Assessed at 3 months of corrected age]

   Percent body fat estimated by air displacement plethysmography

Secondary Outcome Measures

1. Growth [Birth to 3 months of corrected age]

   Weekly weight gain in grams

2. Length [3 months of corrected age]

   Length in cm at 3 months of corrected age

3. Head Circumference [3 months of corrected age]

   Head circumference in cm at 3 months of corrected age

4. Body Mass Index [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 [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 [Birth to 3 months of corrected age]

   Determined by molecular analyses of bacteria in fecal samples

2. Changes in Metabolic Pathways [Birth to 3 months of corrected age]

   Determined by molecular analyses of serum samples

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day to 14 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Gestational age between 28 and 32 weeks of gestation

Exclusion Criteria:

• Gastrointestinal or neurologic malformations

• Terminal illness requiring limited or withheld support

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233

Sponsors and Collaborators

• University of Alabama at Birmingham
• National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 14, 2018

More Information

Publications

None provided.

• Responsible Party: Ariel A. Salas, Assistant Professor, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03575897
• Other Study ID Numbers: 300001753; 2U54MD000502
• First Posted: Jul 3, 2018
• Last Update Posted: Feb 11, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Ariel A. Salas, Assistant Professor, University of Alabama at Birmingham: Premature Infants; Body composition
• Additional relevant MeSH terms: Body Weight

Study Results

Participant Flow

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	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). 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)	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. 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)
Period Title: Overall Study
STARTED	25	25
COMPLETED	13	12
NOT COMPLETED	12	13

Baseline Characteristics

Arm/Group Title	Intervention Group	Control Group	Total
Arm/Group Description	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). 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)	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. 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)	Total of all reporting groups
Overall Participants	25	25	50
Age (Count of Participants)
<=18 years	25 100%	25 100%	50 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (Weeks) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Weeks]	31	30	30
Sex: Female, Male (Count of Participants)
Female	10 40%	14 56%	24 48%
Male	15 60%	11 44%	26 52%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	11 44%	12 48%	23 46%
White	14 56%	13 52%	27 54%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	25 100%	25 100%	50 100%

Outcome Measures

1. Primary Outcome

Title	Infant Body Composition
Description	Percent body fat estimated by air displacement plethysmography
Time Frame	Assessed at 3 months of corrected age

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	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). 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)	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. 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)
Measure Participants	12	13
Mean (Standard Deviation) [percentage of body fat]	21 (4)	19 (6)

2. Secondary Outcome

Title	Growth
Description	Weekly weight gain in grams
Time Frame	Birth to 3 months of corrected age

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	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). 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)	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. 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)
Measure Participants	13	12
Median (Inter-Quartile Range) [grams/kg/day]	8	9

3. Secondary Outcome

Title	Length
Description	Length in cm at 3 months of corrected age
Time Frame	3 months of corrected age

Outcome Measure Data

Analysis Population Description

2 infants in the control group did not have a length measurement at 3 months of corrected age

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	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). 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)	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. 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)
Measure Participants	13	10
Median (Inter-Quartile Range) [cm]	59	60

4. Secondary Outcome

Title	Head Circumference
Description	Head circumference in cm at 3 months of corrected age
Time Frame	3 months of corrected age

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	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). 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)	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. 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)
Measure Participants	12	10
Median (Inter-Quartile Range) [cm]	40	41

5. Secondary Outcome

Title	Body Mass Index
Description	Weight and height at 3 months of corrected age combined to report BMI in kg/m^2
Time Frame	3 months of corrected age

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	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). 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)	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. 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)
Measure Participants	13	12
Median (Inter-Quartile Range) [kg/m^2]	5	6

6. Secondary Outcome

Title	Infant Body Composition
Description	Percent body fat estimated by air displacement plethysmography
Time Frame	Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	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). 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)	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. 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)
Measure Participants	18	17
Mean (Standard Deviation) [percentage of body fat]	14 (5)	14 (3)

7. Other Pre-specified Outcome

Title	Changes in Intestinal Microbiome
Description	Determined by molecular analyses of bacteria in fecal samples
Time Frame	Birth to 3 months of corrected age

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Other Pre-specified Outcome

Title	Changes in Metabolic Pathways
Description	Determined by molecular analyses of serum samples
Time Frame	Birth to 3 months of corrected age

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	6 months
Arm/Group Title	Intervention Group		Control Group
Arm/Group Description	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). 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)		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. 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)
All Cause Mortality
	Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Serious Adverse Events
	Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.