Effects of Probiotic Mixture Supplementation and Evaluation of Intestinal Mucosal Tolerance and Gut Microbiome in Newborns With Perinatal Asphyxia Receiving Hypothermic Treatment (VISNAT)
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|ClinicalTrials.gov Identifier: NCT04145713|
Recruitment Status : Not yet recruiting
First Posted : October 31, 2019
Last Update Posted : October 31, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Asphyxia Neonatorum Morbidity;Newborn||Dietary Supplement: Probiotic mixture Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, placebo-controlled, blinded, multicentre|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Estimated Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||January 1, 2022|
|Experimental: Probiotic group||
Dietary Supplement: Probiotic mixture
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.
|Placebo Comparator: Placebo group||
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.
- Morbidity [ Time Frame: 18 months ]Severe disability according to BAYLEY MENTAL DEVELOPMENT IINDEX
- Mortality [ Time Frame: 18 months ]Death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04145713
|Bari, BA, Italy, 70124|