Weight Gain
Conditions
Keywords
Growth, Preterm Infants, Beta-palmitate, Infant formula, Human milk
Brief summary
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.
Detailed description
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.
Interventions
OTHEREX_IMF
Infant formula with large amounts of beta-palmitate (about 60%).
OTHERST_IMF
Infant formula with low amounts beta-palmitate (about 10%).
Sponsors
Istituto di Ricerca Pediatrica Città della Speranza
Bunge Loders Croklaan
Ospedali Riuniti Ancona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Weeks to 32 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight gain | From birth to 36 weeks of gestational age or until discharge if this occurred before. | Body weight will be daily measured by using an electronic balance (g/kg). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool biochemical composition - Hydroxylic acids | At 32 and then at 36 weeks of gestational age or until discharge if this occurred before. | Fecal hydroxylic acids will be measured by high-resolution capillary chromatography |
| Infant formula intakes | From birth to 36 weeks of gestational age or until discharge if this occurred before. | Cumulative infants formulas intakes (mL/kg). |
| Crying | For 1 consecutive day at 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before. | Crying duration will be electronically recorded by a unidirectional microphone (hours/day). |
| Physical activity | For 1 consecutive day at 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.. | The number of spontaneous movements per hour will be electronically measured by Kinect system. |
| Stooling pattern | At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before. | Stooling pattern will be reported by the parents according to on the Bristol stool form scale (consistency). |
| Stool biochemical composition - Total fatty acids | At 32 and then at 36 weeks of gestational age or until discharge if this occurred before. | Total fatty acids in the stool samples will be measured by gas chromatography (mg/g of dry feces). |
| Stool biochemical composition - Palmitic acid | At 32 and then at 36 weeks of gestational age or until discharge if this occurred before. | Palmitic acid in the stool samples will be measured by gas chromatography (mg/g of dry feces). |
| Stool biochemical composition - Calcium | At 32 and then at 36 weeks of gestational age or until discharge if this occurred before. | Fecal calcium will be measured by inductively coupled plasma emission spectrometry. |
| Stool biochemical composition - Phosphorus | At 32 and then at 36 weeks of gestational age or until discharge if this occurred before. | Fecal phosphorus will be measured by inductively coupled plasma emission spectrometry |
| Human milk intakes | From birth to 36 weeks of gestational age or until discharge if this occurred before. | Cumulative human milk intakes (mL/kg). |
| Parenteral nutrition intakes - cumulative volume | From birth to 36 weeks of gestational age or until discharge if this occurred before. | Cumulative parenteral nutrition intakes (mL/kg). |
| Parenteral nutrition intakes - amino acids | From birth to 36 weeks of gestational age or until discharge if this occurred before. | Cumulative intravenous amino acid intakes (g/kg). |
| Parenteral nutrition intakes - glucose | From birth to 36 weeks of gestational age or until discharge if this occurred before. | Cumulative intravenous glucose intakes (g/kg). |
| Parenteral nutrition intakes - lipids | From birth to 36 weeks of gestational age or until discharge if this occurred before. | Cumulative intravenous lipid intakes (g/kg). |
| Parenteral nutrition duration | From birth to 36 weeks of gestational age or until discharge if this occurred before. | Duration of parenteral nutrition (days) |
| Urinary dicarboxylic acid excretion | At 32 and then at 36 weeks of gestational age or until discharge if this occurred before. | Urinary dicarboxylic acids will be measured by gas chromatography-mass spectrometry (mmol/mol of creatinine). |
| Body weight | At 32, 34 and 36 weeks of gestational age or until discharge if this occurred before and then at 24 months of corrected age.. | Body weight will be measured by using an electronic balance (grams). |
| Total body length | 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 will be measured by using a stadiometer (cm). |
| Head circumference | 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 will be measured by using a unstretchable tape (cm). |
| Blood biochemistry - Glycaemia | At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before. | Glucose concentrations in blood (mg/dL). |
| Blood biochemistry - Triglycerides | At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before. | Triglyceride concentrations in blood (mg/dL). |
| Blood biochemistry - Cholesterol | At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before. | Plasma cholesterol by gas chromatography-mass spectrometry (mg/dL). |
| Blood biochemistry - Phospholipids | At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before. | Plasma phospholipids by gas chromatography (mg/dL). |
| Blood biochemistry - Fatty acids | At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before. | Plasma total fatty acids by gas chromatography (mg/dL). |
| Blood biochemistry - Urea | At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before. | Urea concentrations in plasma (mg/dL). |
| Blood biochemistry - Bilirubin | At 7 and 42 days of postnatal age. | Total and conjugated bilirubin concentrations (mg/dL). |
| Blood biochemistry - Electrolytes | At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before. | Na+, K+, Ca2+, Cl- and standard base excess (mmol/L). |
| Blood biochemistry - Calcium | At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before. | Calcium concentrations in blood (mg/dL). |
| Blood biochemistry - Phosphorus | At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before. | phosphorus concentrations in blood (mg/dL). |
| Total body water | At 36 weeks of gestational age or until discharge if this occurred before. | Total body water (% of body weight) will be measured by the deuterium dilution method. |
| Stool bifidobacteria | At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before. | Number of bifidobacteria per gram of feces will be measured by using fluorescent in situ hybridization. |
| Gastrointestinal problems | Daily from birth to 36 weeks of gestational age or until discharge if this occurred before. | The incidence of gastrointestinal problems such as abdominal distension, gastric residuals, reflux and vomiting. |
| In-hospital death | Daily from birth to 36 weeks of gestational age or until discharge if this occurred before. | The incidence of death during the hospital stay. |
| Complications of prematurity | Daily from birth to 36 weeks of gestational age or until discharge if this occurred before. | 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. |
| Neurodevelopmental assessment | At 24 months of corrected age. | Neurodevelopment will be assessed by the Bayley test III. |
| Urinary urea | At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before. | Urea concentrations in urine (mg/dL). |
| Stool biochemical composition - Magnesium | At 32 and then at 36 weeks of gestational age or until discharge if this occurred before. | Fecal magnesium will be measured by inductively coupled plasma emission spectrometry. |
| Urinary phosphorus | At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before. | Phosphorus concentrations in urine (mg/dL). |
| Liver function tests | At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before. | Plasma alkaline phosphatase (ALP, IU/L), aspartate transaminase (AST, IU/L), alanine aminotransferase (ALT, IU/L) and gamma glutamyltranspeptidase concentrations (γ-GT, IU/L). |
| Parathyroid hormone | At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before. | Parathyroid hormone concentrations in blood (pg/mL). |
| Metabolic complications | Daily from birth to 36 weeks of gestational age or until discharge if this occurred before. | hypo/hypernatremia, hypo/hyperkalemia, hypo/hyperchloremia, hypo/hypercalcemia, hypo/hyperparathyroidism, metabolic acidosis, hypo/hyperglycaemia, hypertriglyceridemia and elevated urea. |
| Urinary calcium | At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before. | Calcium concentrations in urine (mg/dL). |
Countries
Italy
Contacts
Primary ContactVirgilio Carnielli, MD, PHD
Backup ContactAlessio Correani, MSc, PHD
Outcome results
None listed