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

NCT04145713 | Unknown Phase 3

• 1 other identifier: VISNAT
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Asphyxia Neonatorum; Morbidity;Newborn

Outcome Measures

Primary Outcomes (2)

• Morbidity

  Severe disability according to BAYLEY MENTAL DEVELOPMENT IINDEX

  18 months

• Mortality

  Death

  18 months

Study Arms (2)

Probiotic group

EXPERIMENTAL

Dietary Supplement: Probiotic mixture

Placebo group

PLACEBO COMPARATOR

Other: Placebo

Interventions

Probiotic mixture DIETARY_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.

Probiotic group

Placebo OTHER

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.

Placebo group

Eligibility Criteria

• Age: Up to 6 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Policlinico Hospital: lead

Study Sites (1)

Nicola Laforgia

Bari, BA, 70124, Italy

Location

MeSH Terms

Conditions

Asphyxia Neonatorum

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, placebo-controlled, blinded, multicentre

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 31, 2019
• Study Start: January 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: October 31, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)