An interventional study of EX_IMF and ST_IMF in Weight Gain, sponsored by Ospedali Riuniti Ancona. Recruiting at 2 sites in Italy. Open to participants aged 24 Weeks to 32 Weeks. Per ClinicalTrials.gov, last updated 2023-01-25.
Sponsored by Ospedali Riuniti Ancona · Not applicable, Interventional, and Treatment
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.
317 studies on the registry are indexed under Weight Gain; 48 are open to participants now.
This study's planned enrollment of 150 is above the median of 83 across 251 interventional studies indexed under Weight Gain.
Browse Weight Gain studies →Ospedali Riuniti Ancona is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Infants will receive infants formula with large amounts of beta-palmitate (EX_IMF).
Other: EX_IMF
Infants will receive infants formula with low amounts of beta-palmitate (ST_IMF).
Other: ST_IMF
Infants will receive human milk (HM).
Infant formula with large amounts of beta-palmitate (about 60%).
Infant formula with low amounts beta-palmitate (about 10%).
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.
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
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.
Started Jan 2023 (actual). Primary completion is estimated for Dec 2025, 35 months after the start.
Of 95 non-industry interventional studies with no phase under Weight Gain, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 35 months is above that.
Counting every sponsor, half of 101 studies reached it within 27 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ospedali Riuniti Ancona