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

ConditionWeight Gain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age24-32
SponsorOspedali Riuniti Ancona

About this trial

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 criteria

Qualifiers

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,

Disqualifiers

congenital malformations, genetic, metabolic and endocrine disorders,

suspicious infection at enrollment,

intrauterine growth restriction (<10th centile) at enrollment,

maternal diabetes requiring insulin therapy,

Trial design

Treatments tested in this trial

  • EX_IMF
  • ST_IMF

Treatment groups

150 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Ospedali Riuniti Ancona

Lead sponsor

Istituto di Ricerca Pediatrica Città della Speranza

Collaborator

Bunge Loders Croklaan

Collaborator