Late-Onset Neonatal SepsisNCT04424667
Clinical Impact of Donor Milk Pasteurized by HTST Treatment in Preterm Infants
A study testing donor milk in people with Late-Onset Neonatal Sepsis, run by Carmen Rosa Pallas at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Late-Onset Neonatal Sepsis
- What is being tested?
- donor milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Jun 2020to 15 Sep 2023
- 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 Up to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
About this study
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
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.
Read the 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.
- Conditions
- Late-Onset Neonatal Sepsis
- Being tested
- donor milk
- Keywords
- neonatal sepsis, extremely low birth weight infant, donor milk, HTST pasteurization, Holder pasteurization
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
donor milkOther
pasteurized donor milk
| Study group | Role | What they receive |
|---|---|---|
| Holder pasteurization | Active comparator | Donor milk pasteurized by Holder method (62.5ºC, 30 minutes) Receives: Other: donor milk |
| HTST pasteurization | Experimental | Donor milk pasteurized by High Temperature Short Time (HTST) method (72ºC, 15 seconds) Receives: Other: donor milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological proven late onset sepsis rate
Incidence of Microbiological proven late onset sepsis expressed as a percentage
Measured: 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
Number of CLABSI events per 1000 catheter-days
Measured: 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
Incidence of NEC nad late onset sepsis as a percentage
Measured: From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks
Mortality rate
Percentage of preterm infant died during the study
Measured: From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks
Oxygen supplementation
Percentage of infants with respiratory assistance with fraction of inspired oxygen greater than 0.21 at 36 weeks postmenstrual age
Measured: Assessed up to 24 weeks
Stage 3-5 Retinopathy
Percentage of infants diagnosed with retinopathy by the ophthalmologist
Measured: From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks
Growth velocity
Growth calculated as the weight gain in g/kg/day
Measured: Assessed up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start15 Jun 2020
- Primary completion30 May 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late-Onset Neonatal SepsisStudies of the same condition, open and under way.
- 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
- Model description
- Parallel assignment
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmen Rosa Pallas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carmen Rosa Pallas, Hospital Universitario 12 de Octubre
- Investigators
- Carmen Rosa Pallas Alonso, Study chair, Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424667
- Sponsor's protocol ID
- Neo-HTST
- Status last verified
- Sep 2023
- First submitted
- 3 Jun 2020
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04424667
- Acronym / sponsor ID
- Neo-HTST
- Conditions
- Late-Onset Neonatal Sepsis
- Keywords
- neonatal sepsis, extremely low birth weight infant, donor milk, HTST pasteurization, Holder pasteurization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Carmen Rosa PallasUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 11 Jun 2020 (actual)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Holder pasteurization | Active comparator | Other: donor milkDonor milk pasteurized by Holder method (62.5ºC, 30 minutes) |
| HTST pasteurization | Experimental | Other: donor milkDonor milk pasteurized by High Temperature Short Time (HTST) method (72ºC, 15 seconds) |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| donor milkpasteurized donor milk | Other | HTST pasteurization, Holder pasteurization |
Primary outcome
Microbiological proven late onset sepsis rate
Time frame: From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks
Incidence of Microbiological proven late onset sepsis expressed as a percentage
6 secondary outcomes
Central line associated bloodstream infections (CLABSI) rate
Time frame: 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
Time frame: From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks
Mortality rate
Time frame: From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks
Oxygen supplementation
Time frame: Assessed up to 24 weeks
Stage 3-5 Retinopathy
Time frame: From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks
Growth velocity
Time frame: Assessed up to 24 weeks
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 22 Sep 2023.
- Individual participant dataSharing planned: No
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CLABSI - Central Line Associated Bloodstream Infection, CRBSI - Catheter Related Bloodstream Infection
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.
Carmen Rosa Pallas Alonso study chair
Hospital Universitario 12 de Octubre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing donor milk in people with Late-Onset Neonatal Sepsis, run by Carmen Rosa Pallas at 2 sites in Spain.
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 5 inclusion and 8 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 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Microbiological proven late onset sepsis rate (time frame: From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks). 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 22 Sep 2023.