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

Policlinico Hospital

Status and phase

Unknown

Phase 3

Conditions

Morbidity;Newborn

Asphyxia Neonatorum

Treatments

Dietary Supplement: Probiotic mixture

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04145713

VISNAT

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

Under 6 hours old

Volunteers

Accepts 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.