NCT04424667

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

3 years

First QC Date

June 3, 2020

Last Update Submit

September 21, 2023

Conditions

Late-Onset Neonatal Sepsis

Keywords

neonatal sepsisextremely low birth weight infantdonor milkHTST pasteurizationHolder pasteurization

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Central line associated bloodstream infections (CLABSI) rate

    From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks

  • Necrotizing enterocolitis (NEC) and/or microbiological proven late onset sepsis rate

    From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks

  • Mortality rate

    From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks

  • Oxygen supplementation

    Assessed up to 24 weeks

  • Stage 3-5 Retinopathy

    From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks

  • +1 more secondary outcomes

Study Arms (2)

Holder pasteurization

ACTIVE COMPARATOR

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

Other: donor milk

HTST pasteurization

EXPERIMENTAL

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

Other: donor milk

Interventions

donor milkOTHER

pasteurized donor milk

HTST pasteurizationHolder pasteurization

Eligibility Criteria

AgeUp to 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

SepsisInfectionsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Carmen Rosa Pallas Alonso

    Hospital Universitario 12 de Octubre

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Neonatology Service, MD, PhD

Study Record Dates

First Submitted

June 3, 2020

First Posted

June 11, 2020

Study Start

June 15, 2020

Primary Completion

May 30, 2023

Study Completion

September 15, 2023

Last Updated

September 22, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)