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

Phase 3

• Conditions: Morbidity;Newborn; Asphyxia Neonatorum

• Registration Number: NCT04145713
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-10-29
• Last Update Submitted: 2019-10-29
• Study First Posted: 2019-10-31
• Last Update Posted: 2019-10-31
• Study Start: 2020-01-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Morbidity	18 months	Severe disability according to BAYLEY MENTAL DEVELOPMENT IINDEX
Mortality	18 months	Death

Trial Locations

Locations (1)

Nicola Laforgia; 🇮🇹 Bari, BA, Italy