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

September 21, 2023 updated by: Carmen Rosa Pallas

Clinical and Economic Impact of Supplementation With Donor Milk Pasteurized by HTST Method Versus Holder Method in Extremely Birth Weight Preterm Infants. Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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. These compounds are related to the protection conferred by breast milk against nosocomial sepsis and necrotizing enterocolitis in preterm infants, so it would be of interest to study if there is a clinical benefit in these patients when health professionals are supplementing with donor milk pasteurized by both methods.

The purpose of this study is to compare the incidence of microbiological proven late onset sepsis in newborns under 1000 grams that in the first 28 days of life need to be supplemented with donor milk pasteurized by HTST method versus the Holder method.

This is a randomized double-blind clinical trial with parallel assignment. A total of 305 premature babies with a birth weight of less than 1000 grams will be recruited, admitted to the Neonatology Services of the Hospital 12 de Octubre and the Hospital de La Paz and meet the inclusion criteria. Half of the patients will be supplemented exclusively with donor milk pasteurized by the HTST system and the other half with pasteurized milk by the Holder method. Linear generalized models will be used for longitudinal data analysis.

Study Type

Interventional

Enrollment (Actual)

211

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 weeks (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Holder pasteurization
Donor milk pasteurized by Holder method (62.5ºC, 30 minutes)
Other: donor milk
pasteurized donor milk
Experimental: HTST pasteurization
Donor milk pasteurized by High Temperature Short Time (HTST) method (72ºC, 15 seconds)
Other: donor milk
pasteurized donor milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiological proven late onset sepsis rate
Time Frame: From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks
Incidence of Microbiological proven late onset sepsis expressed as a percentage
From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central line associated bloodstream infections (CLABSI) rate
Time Frame: From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks
Number of CLABSI events per 1000 catheter-days
From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks
Necrotizing enterocolitis (NEC) and/or microbiological proven late onset sepsis rate
Time Frame: From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks
Incidence of NEC nad late onset sepsis as a percentage
From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks
Mortality rate
Time Frame: From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks
Percentage of preterm infant died during the study
From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks
Oxygen supplementation
Time Frame: Assessed up to 24 weeks
Percentage of infants with respiratory assistance with fraction of inspired oxygen greater than 0.21 at 36 weeks postmenstrual age
Assessed up to 24 weeks
Stage 3-5 Retinopathy
Time Frame: From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks
Percentage of infants diagnosed with retinopathy by the ophthalmologist
From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks
Growth velocity
Time Frame: Assessed up to 24 weeks
Growth calculated as the weight gain in g/kg/day
Assessed up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmen Rosa Pallas

Investigators

  • Study Chair: Carmen Rosa Pallas Alonso, Hospital Universitario 12 de Octubre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Actual)

May 30, 2023

Study Completion (Actual)

September 15, 2023

Study Registration Dates

First Submitted

June 3, 2020

First Submitted That Met QC Criteria

June 5, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neo-HTST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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