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

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.

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 Overview

• Status: Unknown
• Conditions: Asphyxia Neonatorum; Morbidity;Newborn
• Intervention / Treatment: Dietary supplement: Probiotic mixture; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • BA
    • Bari, BA, Italy, 70124
      • Nicola Laforgia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 hours (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity	Severe disability according to BAYLEY MENTAL DEVELOPMENT IINDEX	18 months
Mortality	Death	18 months

Collaborators and Investigators

• Sponsor: Policlinico Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2020
• Primary Completion (ANTICIPATED): January 1, 2022
• Study Completion (ANTICIPATED): January 1, 2022

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (ACTUAL): October 31, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 31, 2019
• Last Update Submitted That Met QC Criteria: October 29, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Infant, Newborn, Diseases; Death; Asphyxia; Asphyxia Neonatorum
• Other Study ID Numbers: VISNAT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No