Protein Balance and Body Composition in Preterm Infants

PreTerm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03013374
• Other study ID #: Protein balance and FFM
• Status: Recruiting
• Phase: N/A
• First received: December 30, 2016
• Last updated: January 9, 2017
• Start date: January 2015
• Est. completion date: June 2017

Study information

• Verified date: January 2017
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: Laura Morlacchi, MD
• Phone: +39 0255032483
• Email: laura.morlacchi[@]mangiagalli.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Weeks to 32 Weeks

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Human Milk
• Premature Birth
• PreTerm Birth

Locations

Country	Name	City	State
Italy	NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No