NCT07715513

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
Last Updated

July 20, 2026

Status Verified

June 1, 2026

Enrollment Period

9 months

First QC Date

July 7, 2026

Last Update Submit

July 17, 2026

Conditions

Neonatal Intensive Care Unit

Keywords

Fluide intakenewbornprematuretreatment protocolinfusion

Outcome Measures

Primary Outcomes (1)

  • hidden fluid intake

    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.

Study Arms (1)

case

premature

Procedure: hidden fluid intake

Interventions

hidden fluid intakePROCEDURE

comparaison of additionnel fluids intakes before and after practical modification

case

Eligibility Criteria

Age1 Day+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

premature admitted in neonatal intensive care

You may qualify if:

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

You may not qualify if:

  • newborn without intravenous divice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2026

First Posted

July 20, 2026

Study Start

June 1, 2024

Primary Completion

February 28, 2025

Study Completion

September 30, 2025

Last Updated

July 20, 2026

Record last verified: 2026-06

Locations

FR(1)