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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)

Primary Purpose

Asphyxia Neonatorum, Morbidity;Newborn

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Probiotic mixture
Placebo
Sponsored by
Policlinico Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asphyxia Neonatorum

Eligibility Criteria

undefined - 6 Hours (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Nicola Laforgia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic group

Placebo group

Arm Description

Outcomes

Primary Outcome Measures

Morbidity
Severe disability according to BAYLEY MENTAL DEVELOPMENT IINDEX
Mortality
Death

Secondary Outcome Measures

Full Information

First Posted
October 23, 2019
Last Updated
October 29, 2019
Sponsor
Policlinico Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04145713
Brief Title
Effects of Probiotic Mixture Supplementation and Evaluation of Intestinal Mucosal Tolerance and Gut Microbiome in Newborns With Perinatal Asphyxia Receiving Hypothermic Treatment
Acronym
VISNAT
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Anticipated)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Policlinico Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asphyxia Neonatorum, Morbidity;Newborn

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, placebo-controlled, blinded, multicentre
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic group
Arm Type
Experimental
Arm Title
Placebo group
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic mixture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Morbidity
Description
Severe disability according to BAYLEY MENTAL DEVELOPMENT IINDEX
Time Frame
18 months
Title
Mortality
Description
Death
Time Frame
18 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Hours
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Nicola Laforgia
City
Bari
State/Province
BA
ZIP/Postal Code
70124
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Probiotic Mixture Supplementation and Evaluation of Intestinal Mucosal Tolerance and Gut Microbiome in Newborns With Perinatal Asphyxia Receiving Hypothermic Treatment

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