Clinical trial NCT04424667: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Late-Onset Neonatal Sepsis
Keywords: neonatal sepsis
extremely low birth weight infant
donor milk
HTST pasteurization
Holder pasteurization
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 211
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Microbiological proven late onset sepsis rate
timeFrame: From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks
Secondary outcomes:
measure: Central line associated bloodstream infections (CLABSI) rate
timeFrame: From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks
measure: Necrotizing enterocolitis (NEC) and/or microbiological proven late onset sepsis rate
timeFrame: From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks
measure: Mortality rate
timeFrame: From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks
measure: Oxygen supplementation
timeFrame: Assessed up to 24 weeks
measure: Stage 3-5 Retinopathy
timeFrame: From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks
measure: Growth velocity
timeFrame: Assessed up to 24 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Hospital Universitario 12 de Octubre
name: Carmen Rosa Pallas Alonso
role: STUDY_CHAIR
References: