Multiperfusion Neonatal System

NCT05058534 | Completed

• 1 other identifier: CRC_GHN_2021_004
• Study Type: observational
• Target: 640
• Locations: 1 country
• Sites: 1

Brief Summary

Infusion and parenteral nutrition play an important role in the management of neonatal intensive care patients. Administration of drugs and parenteral nutrition solutions to the patient is performed via different systems including a catheter and a perfusion system. In critically ill, high risk neonates, use of these systems is associated with complications such as infections, interactions between drugs simultaneously infused on the same route (precipitates, catheter obstruction), less effective treatment due to modified amount of drug administered compared to expected or to compatibility issues between drugs. Sepsis and reduction of treatment efficacy can have an impact on survival or subsequent neurodevelopment. Late onset sepsis is one of the most frequent complications in very premature infants born before 33 weeks gestational age and most of those infections occur in infants requiring a perfusion system and an intravenous catheter. In this context, a new multiperfusion device was developed (Multiline Néo®, Doran, France) to remove access to the infusion system from the incubator where high temperature and humidity favour bacterial growth. But also to allow the administration of several drug solutions simultaneously avoiding contact between drugs. Our hypothesis is that the new perfusion system helps to reduce the risk of infections, without increase in costs.

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

• Occurence of infection

  Number of infections per 1000 catheter days, per patient during hospital stay

  through study completion, an average of 60 days

Study Arms (2)

Very preterm infants born between November 30, 2018 and November 30, 2019

Infants born between November 30, 2018 - November 30, 2019, before implementation of the new multiperfusion neonatal system

Very preterm infants born between December 1st, 2019 and December 31st, 2022

Infants born between January 1rst, 2019 - December 31st, 2022, after implementation of the new multiperfusion neonatal system

Device: Multiline Neo®

Interventions

Multiline Neo® DEVICE

Multiperfusion neonatal system

Very preterm infants born between December 1st, 2019 and December 31st, 2022

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Infants born between November 30, 2018 and December 31, 2022, at a gestational age below 33 weeks, and hospitalized in the Neonatal unit of Croix-Rousse hospital

You may qualify if:

• Born between November 30, 2018 and December 31, 2022,
• Gestational age below 33 weeks

You may not qualify if:

• Severe malformation and / or disease requiring heavy surgical management in the neonatal period
• Admitted at croix rousse hospital after the third day of life

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civil de Lyon

Lyon, Auvergne-Rhône-Alpes, 69004, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 27, 2021
• Study Start: November 1, 2018
• Primary Completion: November 1, 2018
• Study Completion: December 31, 2022
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)