Protein Balance and Body Composition in Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-06-30

Brief Summary

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The adequacy of the quality of protein supply could influence the rate and the relative composition of weight gain in very low birth weight preterm infants.

Aim of the study is to investigate protein balance according to feeding regimen and the association between human milk feeding and fat free mass content at term corrected age in a cohort of very low birth weight infants.

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Detailed Description

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Nutritional management of preterm infants aims to approximate tissue growth and body composition of a foetus of same postconceptional age. The adequacy of the quality of protein supply could influence the rate and the relative composition of weight gain.

Aim of the study is to investigate protein balance according to feeding regimen and the association between exclusive human milk feeding and fat free mass content at term corrected age in a cohort of very low birth weight infants.

A prospective observational study. Infants are included according to inclusion criteria. Enrollment is performed at hospital discharge. Infants are divided into two groups (exclusively human milk or exclusively formula) according to own mother's milk availability. At enrollment macronutrients' intakes and protein balance are determined. Anthropometric measurements and body composition are also assessed. Nutritional composition of human milk is calculated by infrared spectroscopy (MIRIS® AB, Uppsala, Sweden). Protein balance is determined according to nitrogen balance standard method. Body composition is assessed by an air-displacement plethysmography system system (PEA POD Infant Body Composition System, COSMED SRL, Roma, Italy). At term corrected age anthropometry and body composition assessments are repeated.

Conditions

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PreTerm Birth Human Milk

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Human milk fed infants

Infants fed fortified human milk at enrollment

Any intervention is performed. Groups distinction is made according to own mother's milk availability.

No interventions assigned to this group

Preterm formula

Infants fed preterm formula milk at enrollment.

Any intervention is performed. Groups distinction is made according to own mother's milk availability.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* gestational age ≤32 weeks
* birth weight \< 1500 grams
* birth weight ≥10th percentile according to Fenton's growth chart
* stable clinical conditions at discharge
* feeding by mouth with either exclusively human milk or formula at discharge

Exclusion Criteria

* congenital or chromosomal abnormalities
* conditions that could interfere with growth such as chronic lung disease, neurological disorders, metabolic, cardiac disease and abdominal surgery, renal failure and/or sepsis (defined as a positive blood culture).

Minimum Eligible Age

23 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No