Protein Balance and Body Composition in Preterm Infants

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

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.

Study Overview

• Status: Unknown
• Conditions: PreTerm Birth; Human Milk

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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20122
    • Recruiting
    • NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
    • Contact: Laura Morlacchi, MD; Phone Number: +39 0255032483; Email: laura.morlacchi@mangiagalli.it
    • Principal Investigator: Laura Morlacchi, MD
    • Sub-Investigator: Paola Roggero, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Infants are enrolled at time of hospital discharge. Infants with gestational age ≤32 weeks, birth weight < 1500 grams and ≥10th percentile according to Fenton's growth chart, having stable clinical conditions and feeding by mouth with either exclusively human milk or formula at discharge were included. Exclusion criteria were the following: infants affected by either congenital or chromosomal abnormalities or conditions that could interfere with growth, such as chronic lung disease (as defined based on the classification of Jobe and Bancalari), neurological disorders, metabolic, cardiac disease and abdominal surgery, renal failure and/or sepsis (defined as a positive blood culture).

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protein balance	Protein balance will be determined according to nitrogen balance standard method and defined as the difference between daily nitrogen intake and daily urinary nitrogen excretion. Nitrogen intake will be measured from the amount of total protein intake (i.e. grams of nitrogen intake=grams of protein intake/6.25). Urinary urea nitrogen excretion will be considered representative of total nitrogen loss. Urinary urea will be calculated from urine specimens collected by cotton balls.	at hospital discharge (that is 35-36 post conceptional weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fat free mass content	Body composition will be assessed by an air-displacement plethysmography system (PEA POD Infant Body Composition System, COSMED SRL, Roma, Italy). The PEA POD assesses fat mass and fat-free mass by direct measurements of body mass and volume and the application of a classic densitometric model.	Term corrected age (that is 40 post conceptional weeks)

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Investigators: Principal Investigator: Laura Morlacchi, MD, Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Publications and helpful links

General Publications

• Morlacchi L, Roggero P, Gianni ML, Bracco B, Porri D, Battiato E, Menis C, Liotto N, Mallardi D, Mosca F. Protein use and weight-gain quality in very-low-birth-weight preterm infants fed human milk or formula. Am J Clin Nutr. 2018 Feb 1;107(2):195-200. doi: 10.1093/ajcn/nqx001.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ANTICIPATED): February 1, 2017
• Study Completion (ANTICIPATED): June 1, 2017

Study Registration Dates

• First Submitted: December 30, 2016
• First Submitted That Met QC Criteria: January 4, 2017
• First Posted (ESTIMATE): January 6, 2017

Study Record Updates

• Last Update Posted (ESTIMATE): January 10, 2017
• Last Update Submitted That Met QC Criteria: January 9, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: body composition; protein accretion
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: Protein balance and FFM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED