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NCT Number: NCT04541095

Growth of Preterm Infants Fed a Infant Milk Formula Containing High Versus 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.

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Key information

Conditions

Weight Gain Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

24 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedali Riuniti di Ancona, Ancona, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EX_IMF

Other

Infant formula with large amounts of beta-palmitate (about 60%).

ST_IMF

Other

Infant formula with low amounts beta-palmitate (about 10%).

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

    Crying duration will be electronically recorded by a unidirectional microphone (hours/day).

  2. 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..

    The number of spontaneous movements per hour will be electronically measured by Kinect system.

  3. Stooling pattern

    Time frame: 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).

  4. 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.

    Total fatty acids in the stool samples will be measured by gas chromatography (mg/g of dry feces).

  5. Stool biochemical composition - Palmitic acid

    Time frame: 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).

  6. Stool biochemical composition - Calcium

    Time frame: 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.

  7. Stool biochemical composition - Phosphorus

    Time frame: 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

  8. Stool biochemical composition - Magnesium

    Time frame: 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.

  9. Stool biochemical composition - Hydroxylic acids

    Time frame: 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

  10. Infant formula intakes

    Time frame: From birth to 36 weeks of gestational age or until discharge if this occurred before.

    Cumulative infants formulas intakes (mL/kg).

  11. Human milk intakes

    Time frame: From birth to 36 weeks of gestational age or until discharge if this occurred before.

    Cumulative human milk intakes (mL/kg).

  12. Parenteral nutrition intakes - cumulative volume

    Time frame: From birth to 36 weeks of gestational age or until discharge if this occurred before.

    Cumulative parenteral nutrition intakes (mL/kg).

  13. Parenteral nutrition intakes - amino acids

    Time frame: From birth to 36 weeks of gestational age or until discharge if this occurred before.

    Cumulative intravenous amino acid intakes (g/kg).

  14. Parenteral nutrition intakes - glucose

    Time frame: From birth to 36 weeks of gestational age or until discharge if this occurred before.

    Cumulative intravenous glucose intakes (g/kg).

  15. Parenteral nutrition intakes - lipids

    Time frame: From birth to 36 weeks of gestational age or until discharge if this occurred before.

    Cumulative intravenous lipid intakes (g/kg).

  16. Parenteral nutrition duration

    Time frame: From birth to 36 weeks of gestational age or until discharge if this occurred before.

    Duration of parenteral nutrition (days)

  17. Urinary dicarboxylic acid excretion

    Time frame: 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).

  18. 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..

    Body weight will be measured by using an electronic balance (grams).

  19. 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.

    Total body length will be measured by using a stadiometer (cm).

  20. 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.

    Head circumference will be measured by using a unstretchable tape (cm).

  21. Blood biochemistry - Glycaemia

    Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.

    Glucose concentrations in blood (mg/dL).

  22. Blood biochemistry - Triglycerides

    Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.

    Triglyceride concentrations in blood (mg/dL).

  23. Blood biochemistry - Cholesterol

    Time frame: 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).

  24. Blood biochemistry - Phospholipids

    Time frame: 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).

  25. Blood biochemistry - Fatty acids

    Time frame: 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).

  26. Blood biochemistry - Urea

    Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.

    Urea concentrations in plasma (mg/dL).

  27. Blood biochemistry - Bilirubin

    Time frame: At 7 and 42 days of postnatal age.

    Total and conjugated bilirubin concentrations (mg/dL).

  28. Blood biochemistry - Electrolytes

    Time frame: 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).

  29. Blood biochemistry - Calcium

    Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.

    Calcium concentrations in blood (mg/dL).

  30. Blood biochemistry - Phosphorus

    Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.

    phosphorus concentrations in blood (mg/dL).

  31. Total body water

    Time frame: 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.

  32. Stool bifidobacteria

    Time frame: 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.

  33. Gastrointestinal problems

    Time frame: 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.

  34. In-hospital death

    Time frame: Daily from birth to 36 weeks of gestational age or until discharge if this occurred before.

    The incidence of death during the hospital stay.

  35. Complications of prematurity

    Time frame: 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.

  36. Neurodevelopmental assessment

    Time frame: At 24 months of corrected age.

    Neurodevelopment will be assessed by the Bayley test III.

  37. Urinary urea

    Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.

    Urea concentrations in urine (mg/dL).

  38. Urinary calcium

    Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.

    Calcium concentrations in urine (mg/dL).

  39. Urinary phosphorus

    Time frame: At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.

    Phosphorus concentrations in urine (mg/dL).

  40. Liver function tests

    Time frame: 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).

  41. Parathyroid hormone

    Time frame: 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).

  42. Metabolic complications

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alessio Correani, MSc, PHD

CONTACT

[email protected]

0715962888

Virgilio Carnielli, MD, PHD

CONTACT

[email protected]

0715962045

Sponsors and collaborators

Lead sponsor

Ospedali Riuniti Ancona

Other

Collaborators

  • Bunge Loders Croklaan
  • Istituto di Ricerca Pediatrica Città della Speranza

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Sep 9, 2020
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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