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

Late-Onset Neonatal Sepsis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04424667
• Other study ID #: Neo-HTST
• Status: Completed
• Phase: N/A
• Start date: June 15, 2020
• Est. completion date: September 15, 2023

Study information

• Verified date: September 2023
• Source: Hospital Universitario 12 de Octubre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: September 15, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Late-Onset Neonatal Sepsis
• Neonatal Sepsis

Intervention

Other:
• donor milk
pasteurized donor milk

Locations

Country	Name	City	State
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Carmen Rosa Pallas

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiological proven late onset sepsis rate	Incidence of Microbiological proven late onset sepsis expressed as a percentage	From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks
Secondary	Central line associated bloodstream infections (CLABSI) rate	Number of CLABSI events per 1000 catheter-days	From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks
Secondary	Necrotizing enterocolitis (NEC) and/or microbiological proven late onset sepsis rate	Incidence of NEC nad late onset sepsis as a percentage	From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks
Secondary	Mortality rate	Percentage of preterm infant died during the study	From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks
Secondary	Oxygen supplementation	Percentage of infants with respiratory assistance with fraction of inspired oxygen greater than 0.21 at 36 weeks postmenstrual age	Assessed up to 24 weeks
Secondary	Stage 3-5 Retinopathy	Percentage of infants diagnosed with retinopathy by the ophthalmologist	From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks
Secondary	Growth velocity	Growth calculated as the weight gain in g/kg/day	Assessed up to 24 weeks