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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Morlacchi, MD | Contact | +39 0255032483 | laura.morlacchi@mangiagalli.it | |
| Paola Roggero, MD | Contact | +39 0255032483 | paola.roggero@unimi.it |
| Name | Affiliation | Role |
|---|---|---|
| Laura Morlacchi, MD | Fondazione IRCCS CÃ Granda Ospedale Maggiore Policlinico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NICU, Fondazione IRCCS CÃ Granda Ospedale Maggiore Policlinico | Recruiting | Milan | Milan | 20122 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29529139 | Derived | 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. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Urine
| D000091642 | Urogenital Diseases |