Clinical Trials Logo
  1. Home
  2. Asphyxia Neonatorum
  3. NCT04145713

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

Asphyxia Neonatorum Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04145713
Study type Interventional
Source Policlinico Hospital
Contact
Status Not yet recruiting
Phase Phase 3
Start date January 1, 2020
Completion date January 1, 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04070560 - Effects of Delayed Cord Clamping During Resuscitation of Newborn Near Term and Term Infants N/A
Completed NCT03357250 - Biomarkers And Neurological Outcome in Neonates (BANON)
Completed NCT02572427 - Resident Training Enhanced by New Innovations: Teleintubation N/A
Completed NCT03354208 - Asphyxia Associated Metabolite Biomarker Investigation (AAMBI)
Completed NCT00097097 - Neonatal Resuscitation in Zambia Phase 3
Active, not recruiting NCT03133572 - Neonatal Resuscitation With Supraglottic Airway Trial N/A
Completed NCT01866358 - Intraosseous Infusion for Neonatal Asphyxiated Resuscitation N/A
Completed NCT00136708 - First Breath: Neonatal Resuscitation in Developing Countries N/A
Completed NCT04820504 - Augmented Infant Resuscitator to Enhance Newborn Ventilation N/A
Completed NCT03284528 - Does Placenta Pathology Predict Outcome of Neonates With Hypoxic Ischemic Encephalopathy?" N/A
Completed NCT03278847 - Optimising Newborn Nutrition During Therapeutic Hypothermia.
Recruiting NCT04239508 - Swiss Neonatal Network & Follow-up Group
Recruiting NCT04714775 - Biomarkers And Neurological Outcome in Neonates 2
Active, not recruiting NCT05349175 - Augmented Infant Resuscitator (AIR): Transitioning a Novel Behavior Change Innovation to Drive Newborn Ventilation Skills Enhancement N/A
Completed NCT03606278 - Evaluation of Two Strategies for Debriefing in the Development of Skills for Neonatal Resuscitation N/A
Completed NCT00147030 - TOBY: a Study of Treatment for Perinatal Asphyxia N/A
Withdrawn NCT03913533 - Heart Rate Assessment at Birth Comparing Stethoscope Versus Tap-based Application N/A
Recruiting NCT04867993 - Amikacin Pharmacokinetics to Optimize Dosing Recommendations in Neonates With Perinatal Asphyxia Treated With Hypothermia N/A
Active, not recruiting NCT03179553 - Heart Beat Variability in Neonatal Encephalopathy
Completed NCT03177980 - Fentanyl and Clonidine for Analgesia During Hypothermia in Term Asphyxiated Infants