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| Name | Class |
|---|---|
| Istituto di Ricerca Pediatrica Città della Speranza | UNKNOWN |
| Bunge Loders Croklaan | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EX_IMF group | Experimental | Infants will receive infants formula with large amounts of beta-palmitate (EX_IMF). |
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| ST_IMF group | Active Comparator | Infants will receive infants formula with low amounts of beta-palmitate (ST_IMF). |
|
| HM group | No Intervention | Infants will receive human milk (HM). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EX_IMF | Other | Infant formula with large amounts of beta-palmitate (about 60%). |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Weight gain | Body weight will be daily measured by using an electronic balance (g/kg). | From birth to 36 weeks of gestational age or until discharge if this occurred before. |
| Measure | Description | Time Frame |
|---|---|---|
| Crying | Crying duration will be electronically recorded by a unidirectional microphone (hours/day). | For 1 consecutive day at 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before. |
| Physical activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Virgilio Carnielli, MD, PHD | Contact | 0715962045 | v.carnielli@staff.univpm.it | |
| Alessio Correani, MSc, PHD | Contact | 0715962888 | a.correani@pm.univpm.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedali Riuniti di Ancona | Recruiting | Ancona | 60123 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10429008 | Background | Ehrenkranz RA, Younes N, Lemons JA, Fanaroff AA, Donovan EF, Wright LL, Katsikiotis V, Tyson JE, Oh W, Shankaran S, Bauer CR, Korones SB, Stoll BJ, Stevenson DK, Papile LA. Longitudinal growth of hospitalized very low birth weight infants. Pediatrics. 1999 Aug;104(2 Pt 1):280-9. doi: 10.1542/peds.104.2.280. | |
| 2057024 | Background |
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| ID | Term |
|---|---|
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ST_IMF |
| Other |
Infant formula with low amounts beta-palmitate (about 10%). |
|
The number of spontaneous movements per hour will be electronically measured by Kinect system.
| 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). | 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). | 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). | At 32 and then at 36 weeks of gestational age or until discharge if this occurred before. |
| Stool biochemical composition - Calcium | Fecal calcium will be measured by inductively coupled plasma emission spectrometry. | 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 | 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. | 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 | 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). | From birth to 36 weeks of gestational age or until discharge if this occurred before. |
| Human milk intakes | Cumulative human milk intakes (mL/kg). | 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). | 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). | 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). | 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). | From birth to 36 weeks of gestational age or until discharge if this occurred before. |
| Parenteral nutrition duration | Duration of parenteral nutrition (days) | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | At 7 and 42 days of postnatal age. |
| Blood biochemistry - Electrolytes | Na+, K+, Ca2+, Cl- and standard base excess (mmol/L). | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | At 24 months of corrected age. |
| Urinary urea | Urea concentrations in urine (mg/dL). | 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). | 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). | 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). | 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). | 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. | Daily from birth to 36 weeks of gestational age or until discharge if this occurred before. |
| Istituto di Ricerca Città della Speranza | Not yet recruiting | Padua | 35127 | Italy |
|
| Hack M, Breslau N, Weissman B, Aram D, Klein N, Borawski E. Effect of very low birth weight and subnormal head size on cognitive abilities at school age. N Engl J Med. 1991 Jul 25;325(4):231-7. doi: 10.1056/NEJM199107253250403. |
| 7990660 | Background | Innis SM, Dyer R, Nelson CM. Evidence that palmitic acid is absorbed as sn-2 monoacylglycerol from human milk by breast-fed infants. Lipids. 1994 Aug;29(8):541-5. doi: 10.1007/BF02536625. |
| 16540799 | Background | Straarup EM, Lauritzen L, Faerk J, Hoy Deceased CE, Michaelsen KF. The stereospecific triacylglycerol structures and Fatty Acid profiles of human milk and infant formulas. J Pediatr Gastroenterol Nutr. 2006 Mar;42(3):293-9. doi: 10.1097/01.mpg.0000214155.51036.4f. |
| 8985844 | Background | Carnielli VP, Luijendijk IH, Van Goudoever JB, Sulkers EJ, Boerlage AA, Degenhart HJ, Sauer PJ. Structural position and amount of palmitic acid in infant formulas: effects on fat, fatty acid, and mineral balance. J Pediatr Gastroenterol Nutr. 1996 Dec;23(5):553-60. doi: 10.1097/00005176-199612000-00007. |
| 7733025 | Background | Carnielli VP, Luijendijk IH, van Goudoever JB, Sulkers EJ, Boerlage AA, Degenhart HJ, Sauer PJ. Feeding premature newborn infants palmitic acid in amounts and stereoisomeric position similar to that of human milk: effects on fat and mineral balance. Am J Clin Nutr. 1995 May;61(5):1037-42. doi: 10.1093/ajcn/61.4.1037. |
| 9462186 | Background | Lucas A, Quinlan P, Abrams S, Ryan S, Meah S, Lucas PJ. Randomised controlled trial of a synthetic triglyceride milk formula for preterm infants. Arch Dis Child Fetal Neonatal Ed. 1997 Nov;77(3):F178-84. doi: 10.1136/fn.77.3.f178. |