Clinical trial NCT03013374: Protein Balance and Body Composition in Preterm Infants
Official title: Protein Balance and Body Composition in Preterm Infants According to Feeding Regimen
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: PreTerm Birth
Human Milk
Keywords: protein accretion
body composition
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 30
Sex: ALL
Minimum age (years): 23
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

Brief 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Protein balance
timeFrame: at hospital discharge (that is 35-36 post conceptional weeks)
Secondary outcomes:
measure: Fat free mass content
timeFrame: Term corrected age (that is 40 post conceptional weeks)
Other outcomes:
Locations:
city: Milan
country: Italy
facility: NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Study officials:
affiliation: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
name: Laura Morlacchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.