Growth of Preterm Infants Fed a Infant Milk Formula Containing High Versus Low Amounts of Beta-palmitate
- Conditions
- Weight Gain
- Interventions
- Other: EX_IMFOther: ST_IMF
- Registration Number
- NCT04541095
- Lead Sponsor
- Ospedali Riuniti Ancona
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EX_IMF group EX_IMF Infants will receive infants formula with large amounts of beta-palmitate (EX_IMF). ST_IMF group ST_IMF Infants will receive infants formula with low amounts of beta-palmitate (ST_IMF).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).
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).
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).
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 - 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 - 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).
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).
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).
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.
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
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.
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
Human milk intakes From birth to 36 weeks of gestational age or until discharge if this occurred before. Cumulative human milk intakes (mL/kg).
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).
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.
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.
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).
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).
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 - 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).
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.
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.
Infant formula intakes From birth to 36 weeks of gestational age or until discharge if this occurred before. Cumulative infants formulas intakes (mL/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 duration From birth to 36 weeks of gestational age or until discharge if this occurred before. Duration of parenteral nutrition (days)
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).
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 - 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).
Neurodevelopmental assessment At 24 months of corrected age. Neurodevelopment will be assessed by the Bayley test III.
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).
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).
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 - 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).
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.
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).
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).
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).
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.
Trial Locations
- Locations (2)
Istituto di Ricerca Città della Speranza
🇮🇹Padua, Italy
Ospedali Riuniti di Ancona
🇮🇹Ancona, Italy