CompletedNot Applicable

Clinical Impact of Donor Milk Pasteurized by HTST Treatment in Preterm Infants

Spain211 participantsStarted 2020-06-15

Plain-language summary

Randomized double-blind clinical trial to compare the incidence of microbiological proven late onset sepsis in extremely preterm infants (\<1000 grams) that are supplemented with donor milk pasteurized by High Temperature Short Time (HTST) method versus the Holder method.

Who can participate

Age range28 Days

SexALL

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Inclusion Criteria (all criteria are necessary) : * Infants weighing 1000 grams or less at birth * Infants born or transferred before the third day of life to the participating centers * Start enteral feeding in the first week of life * Receive any amount of donor milk in the first 28 days of life * Informed consent signed by parents or legal guardians Exclusion Criteria: * Language barrier * Infants with chromosomopathies * Infants with major congenital malformations * Infants with severe asphyxiation (cord pH or first arterial pH \<7) * Infants included in another clinical trial that modifies nutritional management * Infants who previously fed with formula Post-randomization exclusion criteria: \- Randomized infant who do not fulfill inclusion criteria

What they're measuring

Microbiological proven late onset sepsis rate

Timeframe: From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks

Trial details

NCT IDNCT04424667

SponsorCarmen Rosa Pallas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-30

View on ClinicalTrials.gov More Late-Onset Neonatal Sepsis trials