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

NCT04424667 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2023-09-22

No results posted yet for this study

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.

Conditions

  • Late-Onset Neonatal Sepsis

Interventions

OTHER

donor milk

pasteurized donor milk

Sponsors & Collaborators

  • Carmen Rosa Pallas

    lead OTHER

Principal Investigators

  • Carmen Rosa Pallas Alonso · Hospital Universitario 12 de Octubre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2023-05-30
Completion
2023-09-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04424667 on ClinicalTrials.gov