NCT03013374

Protein Balance and Body Composition in Preterm Infants

Protein Balance and Body Composition in Preterm Infants According to Feeding Regimen

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Academic / Other
• Sex: All
• Age: 23 Weeks – 32 Weeks
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• PreTerm Birth
• Human Milk

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-02-01
• Completion: 2017-06-01
• First posted: 2017-01-06
• Last updated: 2017-01-10

Locations

1 site across 1 country: Italy