Protein Balance and Body Composition in Preterm Infants

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Unknown

Conditions: Human Milk; PreTerm Birth

Study type: Observational

Funder types: Other

Identifiers

NCT03013374

Protein balance and FFM

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 23 to 32 weeks old

Volunteers: No Healthy Volunteers

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).

Trial design

30 participants in 2 patient groups

Human milk fed infants

Description:

Infants fed fortified human milk at enrollment Any intervention is performed. Groups distinction is made according to own mother's milk availability.

Preterm formula

Description:

Infants fed preterm formula milk at enrollment. Any intervention is performed. Groups distinction is made according to own mother's milk availability.