Protein Balance and Body Composition in Preterm Infants

NCT03013374 | Unknown

• 1 other identifier: Protein balance and FFM
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

PreTerm Birth; Human Milk

Keywords

protein accretion; body composition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Fat free mass content

  Term corrected age (that is 40 post conceptional weeks)

Study Arms (2)

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.

Eligibility Criteria

• Age: 23 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Milan, 20122, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 29529139 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Laura Morlacchi, MD

  Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Morlacchi, MD

CONTACT

+39 0255032483; laura.morlacchi@mangiagalli.it

Paola Roggero, MD

CONTACT

+39 0255032483; paola.roggero@unimi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2016
• First Posted: January 6, 2017
• Study Start: January 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: June 1, 2017
• Last Updated: January 10, 2017

Record last verified: 2017-01

Locations

IT (1)