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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04424667
Recruitment Status : Active, not recruiting
First Posted : June 11, 2020
Last Update Posted : June 2, 2023
Sponsor:
Information provided by (Responsible Party):
Carmen Rosa Pallas, Hospital Universitario 12 de Octubre

Study Description
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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 pasteurized by High Temperature Short Time (HTST) method versus the Holder method.

Condition or disease Intervention/treatment Phase
Late-Onset Neonatal Sepsis Other: donor milk Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : June 15, 2020
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Growth velocity [ Time Frame: Assessed up to 24 weeks ]
    Growth calculated as the weight gain in g/kg/day


Eligibility Criteria
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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04424667


Locations
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Spain
Hospital 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Carmen Rosa Pallas
Investigators
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Study Chair: Carmen Rosa Pallas Alonso Hospital Universitario 12 de Octubre
More Information
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Responsible Party: Carmen Rosa Pallas, Head of Neonatology Service, MD, PhD, Hospital Universitario 12 de Octubre
ClinicalTrials.gov Identifier: NCT04424667    
Other Study ID Numbers: Neo-HTST
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 2, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carmen Rosa Pallas, Hospital Universitario 12 de Octubre:
neonatal sepsis
extremely low birth weight infant
donor milk
HTST pasteurization
Holder pasteurization
Additional relevant MeSH terms:
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Neonatal Sepsis
Sepsis
Infections
Systemic Inflammatory Response Syndrome
 Inflammation
Pathologic Processes
Infant, Newborn, Diseases