Serial Assessment of Body Fat Accrual in Very Preterm Infants

The University of Alabama at Birmingham

Status: Active, not recruiting

Conditions: Infant,Premature; Adiposity; Body Weight

Treatments: Diagnostic Test: Assessment of infant body composition

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03575897

300001753

2U54MD000502 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 patients

Sex: All

Ages: 1 to 14 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gestational age between 28 and 32 weeks of gestation

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Intervention Group

Experimental 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).

Treatment:

Diagnostic Test: Assessment of infant body composition

Control Group

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Assessment of infant body composition