Neonatal Intensive Care UnitREFININCT07715513
Reducing Fluids Intakes in Neonatal Intensive Care
An observational study of Neonatal Intensive Care Unit, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Neonatal Intensive Care Unit
- What is being tested?
- hidden fluid intake
- Type of treatment
- Surgery or procedure
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2024to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: premature admitted in neonatal intensive care
Who may be able to join
- newborns in neonatal intensive care
- gestational age between 24 to 37 weeks of amenorrhoea
- weight birth between 500g to 4500g
Who cannot join
- newborn without intravenous divice
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Neonatal Intensive Care Unit
- Being tested
- hidden fluid intake
- Keywords
- Fluide intake, newborn, premature, treatment protocol, infusion
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hidden fluid intakeProcedure or surgery
comparaison of additionnel fluids intakes before and after practical modification
| Study group | Role | What they receive |
|---|---|---|
| case | premature Receives: Procedure: hidden fluid intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
hidden fluid intake
Volume in milliliters per kilogram of hidden intakes associated with continuous and intermittent drug treatments administered daily
Measured: At Day 0, day 1, Day 7, Day 14, Day 19.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Jun 2024
- Primary completion28 Feb 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Intensive Care UnitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715513
- Sponsor's protocol ID
- 2026-CF639
- Acronym
- REFINI
- Status last verified
- Jun 2026
- First submitted
- 7 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Fluids Intakes in Neonatal Intensive Care
- ClinicalTrials.gov ID
- NCT07715513
- Acronym / sponsor ID
- REFINI / 2026-CF639
- Conditions
- Neonatal Intensive Care Unit
- Keywords
- Fluide intake, newborn, premature, treatment protocol, infusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| case | – | Procedure: hidden fluid intakepremature |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- premature admitted in neonatal intensive care
Key inclusion criteria (3 listed)
- newborns in neonatal intensive care
- gestational age between 24 to 37 weeks of amenorrhoea
- weight birth between 500g to 4500g
Key exclusion criteria (1 listed)
- newborn without intravenous divice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hidden fluid intakecomparaison of additionnel fluids intakes before and after practical modification | Procedure or surgery | case |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Intensive Care Unit, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hidden fluid intake (time frame: At Day 0, day 1, Day 7, Day 14, Day 19.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.