Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Italy / NCT04541095
Recruiting Not applicable

Growth of Preterm Infants Fed a Infant Milk Formula Containing High Versus Low Amounts of Beta-palmitate

NCT04541095 · tracked via the Priya Life Science Italy tracker
Sponsor
Ospedali Riuniti Ancona
Phase
Not applicable
Started
2023-01-16
Last updated
2023-01-25

Condition(s) studied

Weight Gain

Investigational drug(s) / intervention(s)

EX_IMFST_IMF

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

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

Study 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.

Eligibility

Sex
ALL
Min age
24 Weeks
Max age
32 Weeks
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Weight gain — 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).

Trial sites (2)

FacilityCityRegionStatus
Ospedali Riuniti di Ancona Ancona Italy Recruiting
Istituto di Ricerca Città della Speranza Padua Italy Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04541095 on ClinicalTrials.gov ↗ ← All trials in Italy