Actively Recruiting

Phase Not Applicable
Age: 24Weeks - 32Weeks
All Genders
NCT04541095

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

Led by Ospedali Riuniti Ancona · Updated on 2023-01-25

150

Participants Needed

2

Research Sites

254 weeks

Total Duration

On this page

Sponsors

O

Ospedali Riuniti Ancona

Lead Sponsor

I

Istituto di Ricerca Pediatrica Città della Speranza

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 24Weeks - 32Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Gestational age between 24 and 32 weeks at enrollment
  • Birth weight greater than 750 grams
  • Singleton or twin birth (no triplets or higher)
  • Fraction of inspired oxygen lower than 0.60 at enrollment
  • Feasible enteral feeding
  • Cardiovascular stable condition
  • Informed consent signed by at least one parent or legal guardian
Not Eligible

You will not qualify if you...

  • Congenital malformations, genetic, metabolic, or endocrine disorders
  • Suspicious infection at enrollment
  • Intrauterine growth restriction below the 10th centile at enrollment
  • Maternal diabetes requiring insulin therapy
  • Neonatal asphyxia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

Ospedali Riuniti di Ancona

Ancona, Italy, 60123

Actively Recruiting

2

Istituto di Ricerca Città della Speranza

Padua, Italy, 35127

Not Yet Recruiting

Loading map...

Research Team

V

Virgilio Carnielli, MD, PHD

CONTACT

A

Alessio Correani, MSc, PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here