RecruitingNot ApplicableNCT06954142

Restricted Versus Liberal Fluid Intake for Prevention of Bronchopulmonary Dysplasia

Restricted Versus Liberal Fluid Intake for Prevention of Bronchopulmonary Dysplasia - RELIEF Trial. A Cluster-randomised Multiple Period Cross-over Trial.

Sponsor

University Children's Hospital Basel

Enrollment

750 participants

Start Date

Jul 12, 2025

Study Type

INTERVENTIONAL

Conditions

Bronchopulmonary Dysplasia

Summary

The aim of this study is to determine whether restricted fluid intake (135 ±5 mL/kg/day) compared to liberal fluid intake (165 ±5 mL/kg/day) from day 8 of life reduces the incidence of bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age or prior death in preterm infants born \<30 weeks gestational age.

Eligibility

Min Age: 8 Days

Inclusion Criteria2

Hospitalised preterm infants born before 30 weeks 0 days gestation
Signed informed consent for further research use of health-related data

Exclusion Criteria4

congenital malformations
diseases likely to affect life expectancy, lung function, fluid strategy, or neurodevelopment
renal disease requiring fluid management outside the clinical standard of care
congenital heart disease not including patent ductus arteriosus (PDA)

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Interventions

OTHERFluid restriction

Fluid restriction strategy (fluid target 135 ±5 mL/kg/d)

OTHERLiberal fluid intake

Liberal fluid intake strategy (fluid target 165 ± 5 mL/kg/d)

Locations(9)

Kantonsspital Aarau AG, Klinik für Kinder u. Jugendliche

Aarau, Switzerland

University Children's Hospital Basel (UKBB)

Basel, Switzerland

Inselspital Bern, Kinderklinik

Bern, Switzerland

Kantonsspital Graubünden, Departement Kinder- und Jugendmedizin

Chur, Switzerland

Hôpitaux universitaires de Genève (HUG), Unité de Néonatologie

Geneva, Switzerland

Centre hospitalier universitaire vaudois (CHUV) - Service de néonatologie

Lausanne, Switzerland

Luzerner Kantonsspital, Kinderspital

Lucerne, Switzerland

Ostschweizer Kinderspital & Neonatologie und Frauenklinik KSSG, Perinatalzentrum St. Gallen

Sankt Gallen, Switzerland

UniversitätsSpital Zürich, Klinik für Neonatologie

Zurich, Switzerland

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