Asphyxia NeonatorumPhase 3VISNATNCT04145713
Effects of Probiotic Mixture Supplementation and Evaluation of Intestinal Mucosal Tolerance and Gut Microbiome in Newborns With Perinatal Asphyxia Receiving Hypothermic Treatment
A Phase 3 study testing Probiotic mixture in people with Asphyxia Neonatorum and Morbidity;Newborn, run by Policlinico Hospital at 1 site in Italy.
Trial summary
The VISNAT trial is a PILOT STUDY due to absence of previous evidences in literature on using probiotic in newborns with perinatal asphyxia. It is designed as a randomized, placebo-controlled, blinded, multicentre superiority trial with two parallel groups and a primary outcome of mortality and/or disability at 18… Read more about this study
- Who is it for?
- Ages Up to 6 hoursHealthy volunteers can take part
- Conditions the study is for
- Asphyxia Neonatorum, Morbidity;Newborn
- What is being tested?
- Probiotic mixture
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2020to 1 Jan 2022
- Phase
- Phase 3
- 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 6 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- o Newborns with gestational age >/= 35 weeks and birth weight >/= 1800 grams
- o Intrapartum asphyxia defined according at least one of the following:
- APGAR index at 10 minutes </=5;
- Resuscitation with endotracheal tube or mask IPPV for more then 10 minutes;
- pH </= 7 or excess of base >/= 12 mmol/l on arterial blood gas (ABG) analysis within the first 60 minutes of life
- Moderate/severe Hypoxic-ischemic encephalopathy assessed between 30 and 60 minutes of life according to Sarnat \& Sarnat definition
- Hypothermic treatment. According to the Italian national guidelines on Perinatal Asphyxia and Therapeutic Hypothermia, the hypothermic therapy will be started in the first six hours of life and will last 72 hours.
Who cannot join
- Inability to obtain the informed consent from both parents
- Congenital major malformations or syndromes o Surgical diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Probiotic Mixture Supplementation and Evaluation of Intestinal Mucosal Tolerance and Gut Microbiome in Newborns With Perinatal Asphyxia Receiving Hypothermic Treatment: a Randomized, Multicentric, Blinded, Controlled Trial
The VISNAT trial is a PILOT STUDY due to absence of previous evidences in literature on using probiotic in newborns with perinatal asphyxia.
It is designed as a randomized, placebo-controlled, blinded, multicentre superiority trial with two parallel groups and a primary outcome of mortality and/or disability at 18 months of age.
Read more
After informed consent is obtained from both parents, randomization will be performed as block randomization with a 1:1 allocation using a computer-generated allocation sequence, while the allocation concealment will be performed using locked bags.
Randomization data and allocation list will be stored in a secure place and will not be available to any of the components of the study apart of data collectors.
Participant files will be stored for a period of 10 years after completion of the study.
All the components of the study will be blinded including: participants and their parents, healthcare providers, outcome assessors, data collectors, data analysts.
- Conditions
- Asphyxia Neonatorum, Morbidity;Newborn
- Being tested
- Probiotic mixture, Placebo
- Medical subject headings
- Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic mixtureDietary supplement
The experimental intervention will consist in administrating a high-dose multi-strain probiotic (SIVOMIXXTM) for 30 days in addition to hypothermic therapy. The administration of probiotics will begin during the first 24 hours of hypothermia, at the dose of 1 capsule open in 5 millilitre of water. It will be administered daily for 30 days, either via nasogastric tube or orally.
PlaceboOther
The comparison intervention will consist in administrating placebo for 30 days in addition to hypothermic therapy. The administration of placebo will begin during the first 24 hours of hypothermia, at the dose of 1 capsule open in 5 millilitre of water. It will be administered daily for 30 days, either via nasogastric tube or orally.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Not described Receives: Dietary Supplement: Probiotic mixture |
| Placebo group | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
Severe disability according to BAYLEY MENTAL DEVELOPMENT IINDEX
Measured: 18 months
Mortality
Death
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start1 Jan 2020 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asphyxia NeonatorumStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo-controlled, blinded, multicentre
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Maria Elisabetta Baldassarre, Policlinico Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145713
- Sponsor's protocol ID
- VISNAT
- Acronym
- VISNAT
- Status last verified
- Oct 2019
- First submitted
- 23 Oct 2019
- Last updated
- 31 Oct 2019
- Results posted
- 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 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Probiotic Mixture Supplementation and Evaluation of Intestinal Mucosal Tolerance and Gut Microbiome in Newborns With Perinatal Asphyxia Receiving Hypothermic Treatment: a Randomized, Multicentric, Blinded, Controlled Trial
- ClinicalTrials.gov ID
- NCT04145713
- Acronym / sponsor ID
- VISNAT / VISNAT
- Conditions
- Asphyxia Neonatorum, Morbidity;Newborn
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 31 Oct 2019 (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.
The VISNAT trial is a PILOT STUDY due to absence of previous evidences in literature on using probiotic in newborns with perinatal asphyxia.
It is designed as a randomized, placebo-controlled, blinded, multicentre superiority trial with two parallel groups and a primary outcome of mortality and/or disability at 18 months of age.
After informed consent is obtained from both parents, randomization will be performed as block randomization with a 1:1 allocation using a computer-generated allocation sequence, while the allocation concealment will be performed using locked bags.
Randomization data and allocation list will be stored in a secure place and will not be available to any of the components of the study apart of data collectors.
Participant files will be stored for a period of 10 years after completion of the study.
All the components of the study will be blinded including: participants and their parents, healthcare providers, outcome assessors, data collectors, data analysts.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, placebo-controlled, blinded, multicentre
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: Probiotic mixture |
| Placebo group | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- Up to 6 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- o Newborns with gestational age >/= 35 weeks and birth weight >/= 1800 grams
- APGAR index at 10 minutes </=5;
- Resuscitation with endotracheal tube or mask IPPV for more then 10 minutes;
- pH </= 7 or excess of base >/= 12 mmol/l on arterial blood gas (ABG) analysis within the first 60 minutes of life
Key exclusion criteria (2 listed)
- Inability to obtain the informed consent from both parents
- Congenital major malformations or syndromes o Surgical diseases
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 |
|---|---|---|
| Probiotic mixtureThe experimental intervention will consist in administrating a high-dose multi-strain probiotic (SIVOMIXXTM) for 30 days in addition to hypothermic therapy. The administration of probiotics will begin during the first 24 hours of hypothermia, at the dose of 1 capsule open in 5 millilitre of water. It will be administered daily for 30 days, either via nasogastric tube or orally. | Dietary supplement | Probiotic group |
| PlaceboThe comparison intervention will consist in administrating placebo for 30 days in addition to hypothermic therapy. The administration of placebo will begin during the first 24 hours of hypothermia, at the dose of 1 capsule open in 5 millilitre of water. It will be administered daily for 30 days, either via nasogastric tube or orally. | Other | Placebo group |
Primary outcome
Morbidity
Time frame: 18 months
Severe disability according to BAYLEY MENTAL DEVELOPMENT IINDEX
Mortality
Time frame: 18 months
Death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Probiotic mixture in people with Asphyxia Neonatorum and Morbidity;Newborn, run by Policlinico Hospital at 1 site in Italy.
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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 31 Oct 2019. 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 Italy. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Morbidity (time frame: 18 months). The study lists 2 primary outcomes in all. 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 31 Oct 2019.