Weight GainNCT04541095
Growth of Preterm Infants Fed a Infant Milk Formula Containing High Versus Low Amounts of Beta-palmitate
A study testing EX_IMF and ST_IMF in people with Weight Gain, run by Ospedali Riuniti Ancona at 2 sites in Italy.
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). Read more about this study
- Who is it for?
- Ages 24 to 32 weeks
- Conditions the study is for
- Weight Gain
- What is being tested?
- EX_IMF and ST_IMF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesItaly
- Study dates
- 16 Jan 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Ospedali Riuniti di Ancona
Ancona, 60123
Virgilio Carnielli, MD, PHD, v.carnielli@staff.univpm.it
- Not yet recruiting
Istituto di Ricerca Città della Speranza
Padua, 35127
Paola Cogo, MD, PHD, paola.cogo@uniud.it
About this study
Official title: A Randomized, Multicenter, Controlled Clinical Trial to Assess Weight Gain of Preterm Infants Fed a New Infant Milk Formula Containing High Amounts of Beta-palmitate Versus a Standard Infant Milk Formula Containing Low Amounts of Beta-palmitate
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.
Read the 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.
- Conditions
- Weight Gain
- Being tested
- EX_IMF, ST_IMF
- Keywords
- Growth, Preterm Infants, Beta-palmitate, Infant formula, Human milk
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EX_IMFOther
Infant formula with large amounts of beta-palmitate (about 60%).
ST_IMFOther
Infant formula with low amounts beta-palmitate (about 10%).
| Study group | Role | What they receive |
|---|---|---|
| EX_IMF group | Experimental | Infants will receive infants formula with large amounts of beta-palmitate (EX_IMF). Receives: Other: EX_IMF |
| ST_IMF group | Active comparator | Infants will receive infants formula with low amounts of beta-palmitate (ST_IMF). Receives: Other: ST_IMF |
| HM group | No intervention | Infants will receive human milk (HM). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain
Body weight will be daily measured by using an electronic balance (g/kg).
Measured: From birth to 36 weeks of gestational age or until discharge if this occurred before.
Secondary outcomes (42)
Crying
Crying duration will be electronically recorded by a unidirectional microphone (hours/day).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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).
Measured: From birth to 36 weeks of gestational age or until discharge if this occurred before.
Human milk intakes
Cumulative human milk intakes (mL/kg).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: From birth to 36 weeks of gestational age or until discharge if this occurred before.
Parenteral nutrition duration
Duration of parenteral nutrition (days)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: At 7 and 42 days of postnatal age.
Blood biochemistry - Electrolytes
Na+, K+, Ca2+, Cl- and standard base excess (mmol/L).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 24 months of corrected age.
Urinary urea
Urea concentrations in urine (mg/dL).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Daily from birth to 36 weeks of gestational age or until discharge if this occurred before.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start16 Jan 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Weight GainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedali Riuniti Ancona
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto di Ricerca Pediatrica Città della Speranza, Bunge Loders Croklaan
- Responsible party
- Principal investigator, Virgilio Paolo Carnielli, Ospedali Riuniti Ancona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541095
- Sponsor's protocol ID
- PG-1
- Status last verified
- Jan 2023
- First submitted
- 1 Sep 2020
- Last updated
- 25 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 10429008Hack 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.
PubMed 2057024Innis 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.
PubMed 7990660Straarup 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.
PubMed 16540799Carnielli 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.
PubMed 8985844Carnielli 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.
PubMed 7733025Lucas 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.
PubMed 9462186
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Controlled Clinical Trial to Assess Weight Gain of Preterm Infants Fed a New Infant Milk Formula Containing High Amounts of Beta-palmitate Versus a Standard Infant Milk Formula Containing Low Amounts of Beta-palmitate
- ClinicalTrials.gov ID
- NCT04541095
- Acronym / sponsor ID
- PG-1
- Conditions
- Weight Gain
- Keywords
- Growth, Preterm Infants, Beta-palmitate, Infant formula, Human milk
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ospedali Riuniti AnconaUniversity, hospital or other
- Collaborators
- Istituto di Ricerca Pediatrica Città della Speranza, Bunge Loders Croklaan
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EX_IMF group | Experimental | Other: EX_IMFInfants will receive infants formula with large amounts of beta-palmitate (EX_IMF). |
| ST_IMF group | Active comparator | Other: ST_IMFInfants will receive infants formula with low amounts of beta-palmitate (ST_IMF). |
| HM group | No intervention | –Infants will receive human milk (HM). |
Who may qualify
- Ages
- 24 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EX_IMFInfant formula with large amounts of beta-palmitate (about 60%). | Other | EX_IMF group |
| ST_IMFInfant formula with low amounts beta-palmitate (about 10%). | Other | ST_IMF group |
Primary outcome
Weight gain
Time frame: 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).
42 secondary outcomes
Crying
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
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
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
Time frame: At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.
Stool biochemical composition - Palmitic acid
Time frame: At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.
Stool biochemical composition - Calcium
Time frame: At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.
Stool biochemical composition - Phosphorus
Time frame: At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.
Stool biochemical composition - Magnesium
Time frame: At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.
Stool biochemical composition - Hydroxylic acids
Time frame: At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.
Infant formula intakes
Time frame: From birth to 36 weeks of gestational age or until discharge if this occurred before.
Human milk intakes
Time frame: From birth to 36 weeks of gestational age or until discharge if this occurred before.
Parenteral nutrition intakes - cumulative volume
Time frame: From birth to 36 weeks of gestational age or until discharge if this occurred before.
Parenteral nutrition intakes - amino acids
Time frame: From birth to 36 weeks of gestational age or until discharge if this occurred before.
Parenteral nutrition intakes - glucose
Time frame: From birth to 36 weeks of gestational age or until discharge if this occurred before.
Parenteral nutrition intakes - lipids
Time frame: From birth to 36 weeks of gestational age or until discharge if this occurred before.
Parenteral nutrition duration
Time frame: From birth to 36 weeks of gestational age or until discharge if this occurred before.
Urinary dicarboxylic acid excretion
Time frame: At 32 and then at 36 weeks of gestational age or until discharge if this occurred before.
Body weight
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
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
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
Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
Blood biochemistry - Triglycerides
Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
Blood biochemistry - Cholesterol
Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
Blood biochemistry - Phospholipids
Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
Blood biochemistry - Fatty acids
Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
Blood biochemistry - Urea
Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
Blood biochemistry - Bilirubin
Time frame: At 7 and 42 days of postnatal age.
Blood biochemistry - Electrolytes
Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
Blood biochemistry - Calcium
Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
Blood biochemistry - Phosphorus
Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
Total body water
Time frame: At 36 weeks of gestational age or until discharge if this occurred before.
Stool bifidobacteria
Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
Gastrointestinal problems
Time frame: Daily from birth to 36 weeks of gestational age or until discharge if this occurred before.
In-hospital death
Time frame: Daily from birth to 36 weeks of gestational age or until discharge if this occurred before.
Complications of prematurity
Time frame: Daily from birth to 36 weeks of gestational age or until discharge if this occurred before.
Neurodevelopmental assessment
Time frame: At 24 months of corrected age.
Urinary urea
Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
Urinary calcium
Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
Urinary phosphorus
Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
Liver function tests
Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Background: PubMed 10429008Ehrenkranz 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.
- Background: PubMed 2057024Hack 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.
- Background: PubMed 7990660Innis 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.
- Background: PubMed 16540799Straarup 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.
- Background: PubMed 8985844Carnielli 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.
- Background: PubMed 7733025Carnielli 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.
- Background: PubMed 9462186Lucas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EX_IMF and ST_IMF in people with Weight Gain, run by Ospedali Riuniti Ancona at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Virgilio Carnielli, MD, PHD (0715962045, v.carnielli@staff.univpm.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight gain (time frame: From birth to 36 weeks of gestational age or until discharge if this occurred before.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04541095, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.