Reducing Fluids Intakes in Neonatal Intensive Care (REFINI)

July 17, 2026 updated by: University Hospital, Clermont-Ferrand
During stay in the neonatal intensive care unit, newborns requires various treatments administered intravenously. The hidden fluid intake associated with these infusion can lead to fluid overlad, increasing the risk of complications.This study aims to describe the variation of hidden fluid intake associated with treatment infusion, develop a new care protocol for the administration of intravenous medication in the neonatal intensive care unit, and finally standardize care practices related to the infusion of medication to improve the safety and quality of care for newborns.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France
        • CHU Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

premature admitted in neonatal intensive care

Description

Inclusion Criteria:

  • newborns in neonatal intensive care
  • gestational age between 24 to 37 weeks of amenorrhoea
  • weight birth between 500g to 4500g

Exclusion Criteria:

  • newborn without intravenous divice

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
case
premature
Procedure: hidden fluid intake
comparaison of additionnel fluids intakes before and after practical modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hidden fluid intake
Time Frame: At Day 0, day 1, Day 7, Day 14, Day 19.
Volume in milliliters per kilogram of hidden intakes associated with continuous and intermittent drug treatments administered daily
At Day 0, day 1, Day 7, Day 14, Day 19.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

February 28, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

July 7, 2026

First Submitted That Met QC Criteria

July 17, 2026

First Posted (Actual)

July 20, 2026

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-CF639

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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