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

• ClinicalTrials.gov Identifier: NCT04424667
• Recruitment Status: Unknown
• First Posted: June 11, 2020
• Last Update Posted: July 9, 2020
• Sponsor: Carmen Rosa Pallas
• Information provided by (Responsible Party): Carmen Rosa Pallas, Hospital Universitario 12 de Octubre

Tracking Information

• First Submitted Date: June 3, 2020
• First Posted Date: June 11, 2020
• Last Update Posted Date: July 9, 2020
• Actual Study Start Date: June 15, 2020
• Estimated Primary Completion Date: November 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 5, 2020)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 5, 2020)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Impact of Donor Milk Pasteurized by HTST Treatment in Preterm Infants
• 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
• 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.

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
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Parallel assignment

Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention

• Condition: Late-Onset Neonatal Sepsis

Intervention

Other: donor milk

pasteurized donor milk

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 5, 2020): 305
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 30, 2021
• Estimated Primary Completion Date: November 30, 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 28 Days (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT04424667
• Other Study ID Numbers: Neo-HTST
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Carmen Rosa Pallas, Hospital Universitario 12 de Octubre
• Original Responsible Party: Same as current
• Current Study Sponsor: Carmen Rosa Pallas
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Hospital Universitario 12 de Octubre
• Verification Date: February 2020