Reduced versus higher daily fluids to prevent bronchopulmonary dysplasia in very preterm babies

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

This tests whether giving smaller daily fluid volumes from day 8 of life (about 135 mL/kg/day) instead of larger volumes (about 165 mL/kg/day) lowers the chance of developing BPD or dying before 36 weeks in babies born before 30 weeks.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 750 (estimated)
• Ages: 8 Days and up
• Sex: All
• Sponsor: University Children's Hospital Basel (other)
• Locations: 9 sites (Aarau and 8 other locations)
• Trial ID: NCT06954142 on ClinicalTrials.gov

What this trial studies

Bronchopulmonary dysplasia (BPD) is a common chronic lung problem in babies born very preterm and is associated with prolonged respiratory support and long-term health issues. This trial randomizes hospitalized infants born before 30 weeks to either a restricted fluid regimen (135 ±5 mL/kg/day) or a liberal regimen (165 ±5 mL/kg/day) starting on day 8 of life. The primary outcome is BPD at 36 weeks postmenstrual age or death prior to that age, with monitoring of respiratory support, growth, and safety outcomes. The approach aims to reduce pulmonary interstitial edema without exposing infants to the risks of routine diuretic use.

Who should consider this trial

Good fit: Hospitalized preterm infants born before 30 weeks' gestation whose parents provide informed consent and who meet NICU clinical care criteria are eligible.

Not a fit: Infants with major congenital malformations, renal disease requiring nonstandard fluid management, or certain congenital heart disease (other than PDA) are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, restricting fluids could reduce rates of BPD and the duration of oxygen or ventilator support while avoiding diuretic-related harms.

How similar studies have performed: Some neonatal units use fluid restriction or diuretics empirically and diuretics show short-term lung improvements, but randomized evidence directly comparing liberal versus restricted fluid regimens is limited.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

* 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)

Where this trial is running

Aarau and 8 other locations

• Kantonsspital Aarau AG, Klinik für Kinder u. Jugendliche — Aarau, Switzerland (RECRUITING)
• University Children's Hospital Basel (UKBB) — Basel, Switzerland (RECRUITING)
• Inselspital Bern, Kinderklinik — Bern, Switzerland (RECRUITING)
• Kantonsspital Graubünden, Departement Kinder- und Jugendmedizin — Chur, Switzerland (RECRUITING)
• Hôpitaux universitaires de Genève (HUG), Unité de Néonatologie — Geneva, Switzerland (RECRUITING)
• Centre hospitalier universitaire vaudois (CHUV) - Service de néonatologie — Lausanne, Switzerland (RECRUITING)
• Luzerner Kantonsspital, Kinderspital — Lucerne, Switzerland (RECRUITING)
• Ostschweizer Kinderspital & Neonatologie und Frauenklinik KSSG, Perinatalzentrum St. Gallen — Sankt Gallen, Switzerland (RECRUITING)
• UniversitätsSpital Zürich, Klinik für Neonatologie — Zurich, Switzerland (RECRUITING)

Study contacts

• Principal investigator: Sven Schulzke, Prof.MD — University Children's Hospital Basel
• Study coordinator: Anne Carrer

Conditions: Bronchopulmonary Dysplasia, Fluid Restriction, Preterm Infants