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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-15

Study Completion Date

2023-09-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Late-Onset Neonatal Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Holder pasteurization

Donor milk pasteurized by Holder method (62.5ºC, 30 minutes)

Group Type ACTIVE_COMPARATOR

donor milk

Intervention Type OTHER

pasteurized donor milk

HTST pasteurization

Donor milk pasteurized by High Temperature Short Time (HTST) method (72ºC, 15 seconds)

Group Type EXPERIMENTAL

donor milk

Intervention Type OTHER

pasteurized donor milk

Interventions

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donor milk

pasteurized donor milk

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No