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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04541095
Other study ID # PG-1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 16, 2023
Est. completion date December 2027

Study information

Verified date January 2023
Source Ospedali Riuniti Ancona
Contact Virgilio Carnielli, MD, PHD
Phone 0715962045
Email v.carnielli@staff.univpm.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 2027
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 24 Weeks to 32 Weeks
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
EX_IMF
Infant formula with large amounts of beta-palmitate (about 60%).
ST_IMF
Infant formula with low amounts beta-palmitate (about 10%).

Locations

Country Name City State
Italy Ospedali Riuniti di Ancona Ancona
Italy Istituto di Ricerca Città della Speranza Padua

Sponsors (3)

Lead Sponsor Collaborator
Ospedali Riuniti Ancona Bunge Loders Croklaan, Istituto di Ricerca Pediatrica Città della Speranza

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Secondary 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.
Secondary Physical activity 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..
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary Infant formula intakes Cumulative infants formulas intakes (mL/kg). From birth to 36 weeks of gestational age or until discharge if this occurred before.
Secondary Human milk intakes Cumulative human milk intakes (mL/kg). From birth to 36 weeks of gestational age or until discharge if this occurred before.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary Parenteral nutrition duration Duration of parenteral nutrition (days) From birth to 36 weeks of gestational age or until discharge if this occurred before.
Secondary 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.
Secondary 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..
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary Blood biochemistry - Bilirubin Total and conjugated bilirubin concentrations (mg/dL). At 7 and 42 days of postnatal age.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary Neurodevelopmental assessment Neurodevelopment will be assessed by the Bayley test III. At 24 months of corrected age.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary Liver function tests Plasma alkaline phosphatase (ALP, IU/L), aspartate transaminase (AST, IU/L), alanine aminotransferase (ALT, IU/L) and gamma glutamyltranspeptidase concentrations (?-GT, IU/L). At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
Secondary 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.
Secondary 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.
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