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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
Sponsor:
Information provided by (Responsible Party):
Prof. Maria Elisabetta Baldassarre, Policlinico Hospital

Brief 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 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, placebo-controlled, blinded, multicentre
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
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 Other: Placebo
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.




Primary Outcome Measures :
  1. Morbidity [ Time Frame: 18 months ]
    Severe disability according to BAYLEY MENTAL DEVELOPMENT IINDEX

  2. Mortality [ Time Frame: 18 months ]
    Death



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Inability to obtain the informed consent from both parents
  • Congenital major malformations or syndromes o Surgical diseases

Information from the National Library of Medicine

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


Locations
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Italy
Nicola Laforgia
Bari, BA, Italy, 70124
Sponsors and Collaborators
Policlinico Hospital
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Responsible Party: Prof. Maria Elisabetta Baldassarre, Principal Investigator, Policlinico Hospital
ClinicalTrials.gov Identifier: NCT04145713    
Other Study ID Numbers: VISNAT
First Posted: October 31, 2019    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asphyxia Neonatorum
Asphyxia
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases