Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • EX_IMF

    Other intervention

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

  • ST_IMF

    Other intervention

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

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: EX_IMF groupExperimental treatment 1 intervention
Group B: ST_IMF groupActive comparator 1 intervention
Group C: HM groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Weight gain

Body weight will be daily measured by using an electronic balance (g/kg).

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

Secondary outcomes

1

Crying

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

Time frame
For 1 consecutive day at 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
2

Physical activity

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

Time frame
For 1 consecutive day at 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before..
3

Stooling pattern

Stooling pattern will be reported by the parents according to on the Bristol stool form scale (consistency).

Time frame
At 32, 34 and then at 36 weeks of gestational age or until discharge if this occurred before.
4

Stool biochemical composition - Total fatty acids

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

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

Other outcomes

Sponsors and contacts

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Ospedali Riuniti Ancona

Lead sponsor

Istituto di Ricerca Pediatrica Città della Speranza

Collaborator

Bunge Loders Croklaan

Collaborator

Source ClinicalTrials.gov
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