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NCT Number: NCT04424667

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

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.

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Key information

Conditions

Late-Onset Neonatal Sepsis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infections Inflammation Neonatal Sepsis Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital 12 de Octubre, Madrid, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

donor milk

Other

pasteurized donor milk

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Carmen Rosa Pallas

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 11, 2020
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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