Status:
COMPLETED
Clinical Impact of Donor Milk Pasteurized by HTST Treatment in Preterm Infants
Lead Sponsor:
Carmen Rosa Pallas
Conditions:
Late-Onset Neonatal Sepsis
Eligibility:
All Genders
Up to 28 years
Phase:
NA
Brief 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 pasteurize...
Detailed Description
Donor milk pasteurized by an innovative High Temperature Short Time (HTST) system (patented by researchers) retains more immune and trophic compounds than pasteurized milk by traditional Holder method...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2023
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT04424667
Start Date
June 15 2020
End Date
September 15 2023
Last Update
September 22 2023
Active Locations (2)
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1
Hospital 12 de Octubre
Madrid, Spain, 28041
2
Hospital Universitario La Paz
Madrid, Spain, 28046