SepsisNCT01580826
Pasteurization of Mother's Own Milk for Preterm Infants
A study testing pasteurization of mother's own milk in people with Sepsis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
We hypothesize that short term infection-related benefits of human milk feeding are decreased by the process of pasteurization. Primary objective of the study is to compare the incidence of late-onset sepsis in very low birth weight infants assigned randomly to receive either pasteurized or raw expressed mothers'own… Read more about this study
- Who is it for?
- Ages 1 day to 2 days
- Conditions the study is for
- Sepsis
- What is being tested?
- pasteurization of mother's own milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2006to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 2 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- all patients born before 32 weeks of gestational age and/or with BW below 1500 g admitted to the tertiary NICU of the University Hospitals Leuven within 24 hours of birth
Who cannot join
- died within 24 hours after birth
- no consent
- admitted after 24 hours of birth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pasteurization of Mother's Own Milk for Preterm Infants : a Randomized Trial.
We hypothesize that short term infection-related benefits of human milk feeding are decreased by the process of pasteurization. Primary objective of the study is to compare the incidence of late-onset sepsis in very low birth weight infants assigned randomly to receive either pasteurized or raw expressed mothers'own milk.
Read the detailed description
In this prospective, randomized, controlled trial, all patients born before 32 weeks of gestational age and/or with birth weight below 1500 g admitted to the tertiary neonatal intensive care unit(NICU) of the University Hospitals Leuven within 24 hours of birth, are eligible for inclusion in the study except for infants who died within the first 24 hours. Infants whose mothers intend to breastfeed will be randomly assigned, using a digital system, to receive either raw or pasteurized mother's own milk. The duration of the study is from birth to eight weeks of age or to discharge from the NICU, whichever occurs first. The need to ensure proper handling of the milk precludes true blinding of the caregivers. The institutional review board approved the study and written informed parental consent iss obtained before enrolment.
- Conditions
- Sepsis
- Being tested
- pasteurization of mother's own milk
- Keywords
- pasteurization, human milk, very low birth weight infants
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pasteurization of mother's own milkOther
Also called pasteurization
mother's milk heat treated at 62,5°C for 30 minutes with a Sterifeed® S75 TES pasteurizer.
| Study group | Role | What they receive |
|---|---|---|
| raw milk | No intervention | Infants who were assigned to the raw group received fresh or thawed milk from their own mother, cultured weekly with a semi-quantitative analysis. Raw milk was withheld if it contained any Gram-negative organisms, S. aureus or enterococci. |
| pasteurized milk | Active comparator | Infants who were assigned to pasteurization received own mother's milk heat treated at 62,5°C for 30 minutes with a Sterifeed® S75 TES pasteurizer. Receives: Other: pasteurization of mother's own milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of late-onset sepsis
the incidence of proven late-onset sepsis, occurring more than 48 hours after birth, with growth of a pathogen or coagulase-negative staphylococci (CoNS) cultured from blood, obtained from a peripheral vein under aseptic conditions, combined with the acute onset of two or more predefined clinical signs and, only in case of growth of a CoNS isolate, at least one laboratory parameter of systemic infection (such as elevated C-reactive protein, left shift or leukopenia).
Measured: up to 8 weeks of age
Secondary outcomes (1)
necrotizing enterocolitis
Secondary end points were the incidence of clinical sepsis ; infection site other than bloodstream; the antibiotic utilization rate ; necrotizing enterocolitis stages II and III ; intraventricular hemorrhage or periventricular leucomalacia; need of respiratory support; chronic lung disease ; severe retinopathy of prematurity; the length of NICU stay for survivors and in-NICU mortality.
Measured: up to 8 weeks of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startMar 2006
- Primary completionFeb 2010
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Veerle Cossey, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Veerle Cossey, Dr, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580826
- Sponsor's protocol ID
- ML 3398
- Status last verified
- Nov 2023
- First submitted
- 18 Apr 2012
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pasteurization of Mother's Own Milk for Preterm Infants : a Randomized Trial.
- ClinicalTrials.gov ID
- NCT01580826
- Acronym / sponsor ID
- ML 3398
- Conditions
- Sepsis
- Keywords
- pasteurization, human milk, very low birth weight infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 19 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We hypothesize that short term infection-related benefits of human milk feeding are decreased by the process of pasteurization. Primary objective of the study is to compare the incidence of late-onset sepsis in very low birth weight infants assigned randomly to receive either pasteurized or raw expressed mothers'own milk.
Detailed description
In this prospective, randomized, controlled trial, all patients born before 32 weeks of gestational age and/or with birth weight below 1500 g admitted to the tertiary neonatal intensive care unit(NICU) of the University Hospitals Leuven within 24 hours of birth, are eligible for inclusion in the study except for infants who died within the first 24 hours. Infants whose mothers intend to breastfeed will be randomly assigned, using a digital system, to receive either raw or pasteurized mother's own milk. The duration of the study is from birth to eight weeks of age or to discharge from the NICU, whichever occurs first. The need to ensure proper handling of the milk precludes true blinding of the caregivers. The institutional review board approved the study and written informed parental consent iss obtained before enrolment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| raw milk | No intervention | –Infants who were assigned to the raw group received fresh or thawed milk from their own mother, cultured weekly with a semi-quantitative analysis. Raw milk was withheld if it contained any Gram-negative organisms, S. aureus or enterococci. |
| pasteurized milk | Active comparator | Other: pasteurization of mother's own milkInfants who were assigned to pasteurization received own mother's milk heat treated at 62,5°C for 30 minutes with a Sterifeed® S75 TES pasteurizer. |
Who may qualify
- Ages
- 1 day to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- all patients born before 32 weeks of gestational age and/or with BW below 1500 g admitted to the tertiary NICU of the University Hospitals Leuven within 24 hours of birth
Key exclusion criteria (3 listed)
- died within 24 hours after birth
- no consent
- admitted after 24 hours of birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pasteurization of mother's own milkAlso: pasteurizationmother's milk heat treated at 62,5°C for 30 minutes with a Sterifeed® S75 TES pasteurizer. | Other | pasteurized milk |
Primary outcome
incidence of late-onset sepsis
Time frame: up to 8 weeks of age
the incidence of proven late-onset sepsis, occurring more than 48 hours after birth, with growth of a pathogen or coagulase-negative staphylococci (CoNS) cultured from blood, obtained from a peripheral vein under aseptic conditions, combined with the acute onset of two or more predefined clinical signs and, only in case of growth of a CoNS isolate, at least one laboratory parameter of systemic infection (such as elevated C-reactive protein, left shift or leukopenia).
1 secondary outcome
necrotizing enterocolitis
Time frame: up to 8 weeks of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veerle Cossey, Dr principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pasteurization of mother's own milk in people with Sepsis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of late-onset sepsis (time frame: up to 8 weeks of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.