Growth of Preterm Infants Fed a Infant Milk Formula Containing High Versus Low Amounts of Beta-palmitate

Ospedali Riuniti Ancona150 enrolled

Overview

The aim of this study is to assess weight gain of preterm infants (gestational age lower than 32 weeks) fed infant milk formula with about 60% beta-palmitate (EX\_IMF) vs infant milk formula with similar macronutrient, mineral and fatty acid composition but lower amounts of beta-palmitate (ST\_IMF). Own mother milk (OMM) fed infants will serve as reference group.

A large number of low birth weight infants during their hospital stay experience poor growth and this has been linked to reduced neurodevelopment scores. Several enriched infant milk formulas are available for preterm infants who cannot be fed human milk. The use of infant milk formulas (IMF) enriched with triglycerides similar to human milk lipids have shown to be associated with better fatty acid and mineral intestinal absorption. In this multicenter, randomized, controlled clinical trial, preterm infants (gestational age lower than 32 weeks), who can not be fed human milk, will be randomized to receive IMF with high or low amounts of beta-palmitate (about 60% vs 10%, respectively). A non-randomized own human milk-fed group will be included as a reference. Patients will be on the study diet as soon as possible after birth and till 36 weeks of gestation. Neurodevelopment follow-up will be performed at 24 months corrected age.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Weight Gain

Interventions

EX_IMFOTHER

Infant formula with large amounts of beta-palmitate (about 60%).

ST_IMFOTHER

Infant formula with low amounts beta-palmitate (about 10%).

Eligibility

Sex: ALLMin age: 24 WeeksMax age: 32 Weeks

Medical Language ↔ Plain English

Inclusion Criteria: * gestational age between 24 and 32 weeks of gestation at enrollment, * birth weight greater than 750 grams, * singleton or twin birth (no triplet or higher), * fraction of inspired oxygen lower than 0.60 at enrollment, * feasible enteral feeding, * cardiovascular stable condition, * informed consent form signed by at least one parent or legal guardian. Exclusion Criteria: * congenital malformations, genetic, metabolic and endocrine disorders, * suspicious infection at enrollment, * intrauterine growth restriction (\<10th centile) at enrollment, * maternal diabetes requiring insulin therapy, * neonatal asphyxia.

Locations (2)

Ospedali Riuniti di Ancona

Ancona, Italy

RECRUITING

Istituto di Ricerca Città della Speranza

Padua, Italy

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Weight gain

Body weight will be daily measured by using an electronic balance (g/kg).

Time frame: From birth to 36 weeks of gestational age or until discharge if this occurred before.

Secondary Outcomes

Crying

Crying duration will be electronically recorded by a unidirectional microphone (hours/day).

Time frame: For 1 consecutive day at 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.

Physical activity

The number of spontaneous movements per hour will be electronically measured by Kinect system.

Time frame: For 1 consecutive day at 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before..

Stooling pattern

Stooling pattern will be reported by the parents according to on the Bristol stool form scale (consistency).

Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.

Stool biochemical composition - Total fatty acids

Total fatty acids in the stool samples will be measured by gas chromatography (mg/g of dry feces).

Time frame: At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.

Stool biochemical composition - Palmitic acid

Palmitic acid in the stool samples will be measured by gas chromatography (mg/g of dry feces).

Time frame: At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.

Stool biochemical composition - Calcium

Central Contacts

Virgilio Carnielli, MD, PHD

CONTACT

0715962045 v.carnielli@staff.univpm.it

Alessio Correani, MSc, PHD

CONTACT

0715962888 a.correani@pm.univpm.it

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Fecal calcium will be measured by inductively coupled plasma emission spectrometry.

Time frame: At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.

Stool biochemical composition - Phosphorus

Fecal phosphorus will be measured by inductively coupled plasma emission spectrometry

Time frame: At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.

Stool biochemical composition - Magnesium

Fecal magnesium will be measured by inductively coupled plasma emission spectrometry.

Time frame: At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.

Stool biochemical composition - Hydroxylic acids

Fecal hydroxylic acids will be measured by high-resolution capillary chromatography

Time frame: At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.

Infant formula intakes

Cumulative infants formulas intakes (mL/kg).

Time frame: From birth to 36 weeks of gestational age or until discharge if this occurred before.

Human milk intakes

Cumulative human milk intakes (mL/kg).

Time frame: From birth to 36 weeks of gestational age or until discharge if this occurred before.

Parenteral nutrition intakes - cumulative volume

Cumulative parenteral nutrition intakes (mL/kg).

Time frame: From birth to 36 weeks of gestational age or until discharge if this occurred before.

Parenteral nutrition intakes - amino acids

Cumulative intravenous amino acid intakes (g/kg).

Time frame: From birth to 36 weeks of gestational age or until discharge if this occurred before.

Parenteral nutrition intakes - glucose

Cumulative intravenous glucose intakes (g/kg).

Time frame: From birth to 36 weeks of gestational age or until discharge if this occurred before.

Parenteral nutrition intakes - lipids

Cumulative intravenous lipid intakes (g/kg).

Time frame: From birth to 36 weeks of gestational age or until discharge if this occurred before.

Parenteral nutrition duration

Duration of parenteral nutrition (days)

Time frame: From birth to 36 weeks of gestational age or until discharge if this occurred before.

Urinary dicarboxylic acid excretion

Urinary dicarboxylic acids will be measured by gas chromatography-mass spectrometry (mmol/mol of creatinine).

Time frame: At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.

Body weight

Body weight will be measured by using an electronic balance (grams).

Time frame: At 32, 34 and 36 weeks of gestational age or until discharge if this occurred before and then at 24 months of corrected age..

Total body length

Total body length will be measured by using a stadiometer (cm).

Time frame: At 32, 34 and 36 weeks of gestational age or until discharge if this occurred before and then at 24 months of corrected age.

Head circumference

Head circumference will be measured by using a unstretchable tape (cm).

Time frame: At 32, 34 and 36 weeks of gestational age or until discharge if this occurred before and then at 24 months of corrected age.

Blood biochemistry - Glycaemia

Glucose concentrations in blood (mg/dL).

Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.

Blood biochemistry - Triglycerides

Triglyceride concentrations in blood (mg/dL).

Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.

Blood biochemistry - Cholesterol

Plasma cholesterol by gas chromatography-mass spectrometry (mg/dL).

Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.

Blood biochemistry - Phospholipids

Plasma phospholipids by gas chromatography (mg/dL).

Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.

Blood biochemistry - Fatty acids

Plasma total fatty acids by gas chromatography (mg/dL).

Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.

Blood biochemistry - Urea

Urea concentrations in plasma (mg/dL).

Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.

Blood biochemistry - Bilirubin

Total and conjugated bilirubin concentrations (mg/dL).

Time frame: At 7 and 42 days of postnatal age.

Blood biochemistry - Electrolytes

Na+, K+, Ca2+, Cl- and standard base excess (mmol/L).

Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.

Blood biochemistry - Calcium

Calcium concentrations in blood (mg/dL).

Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.

Blood biochemistry - Phosphorus

phosphorus concentrations in blood (mg/dL).

Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.

Total body water

Total body water (% of body weight) will be measured by the deuterium dilution method.

Time frame: At 36 weeks of gestational age or until discharge if this occurred before.

Stool bifidobacteria

Number of bifidobacteria per gram of feces will be measured by using fluorescent in situ hybridization.

Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.

Gastrointestinal problems

The incidence of gastrointestinal problems such as abdominal distension, gastric residuals, reflux and vomiting.

Time frame: Daily from birth to 36 weeks of gestational age or until discharge if this occurred before.

In-hospital death

The incidence of death during the hospital stay.

Time frame: Daily from birth to 36 weeks of gestational age or until discharge if this occurred before.

Complications of prematurity

The incidence of complications of prematurity such as respiratory distress syndrome (RDS), necrotizing enterocolitis (NEC), patent ductus arteriosus (PDA), intraventricular hemorrhage (IVH), retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD), Periventricular Leukomalacia (PVL), sepsis, and cholestasis.

Time frame: Daily from birth to 36 weeks of gestational age or until discharge if this occurred before.

Neurodevelopmental assessment

Neurodevelopment will be assessed by the Bayley test III.

Time frame: At 24 months of corrected age.

Urinary urea

Urea concentrations in urine (mg/dL).

Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.

Urinary calcium

Calcium concentrations in urine (mg/dL).

Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.

Urinary phosphorus

Phosphorus concentrations in urine (mg/dL).

Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.

Liver function tests

Plasma alkaline phosphatase (ALP, IU/L), aspartate transaminase (AST, IU/L), alanine aminotransferase (ALT, IU/L) and gamma glutamyltranspeptidase concentrations (γ-GT, IU/L).

Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.

Parathyroid hormone

Parathyroid hormone concentrations in blood (pg/mL).

Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.

Metabolic complications

hypo/hypernatremia, hypo/hyperkalemia, hypo/hyperchloremia, hypo/hypercalcemia, hypo/hyperparathyroidism, metabolic acidosis, hypo/hyperglycaemia, hypertriglyceridemia and elevated urea.

Time frame: Daily from birth to 36 weeks of gestational age or until discharge if this occurred before.