Clinical trial Recruiting at 9 sites Interventional Ages 8 Days and up

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

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

Run by University Children's Hospital Basel · NCT06954142 · Data updated 2026-11-12

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.

More Bronchopulmonary Dysplasia trials

Quick facts

Study typeInterventional
Ages8 Days and up
SexAll
Enrollment750 (estimated)
SponsorUniversity Children's Hospital Basel
Academic / other
Locations9 sites (Aarau and 8 other locations)
StatusRecruiting
StartedJuly 12, 2025
Main results expectedDecember 2029
Study endsDecember 2029
Registry record updatedOctober 22, 2026
Trial IDNCT06954142 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

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

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • 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), Service de Néonatologie et Soins Intensifs
    Geneva, Switzerland
    Recruiting
  • Centre hospitalier universitaire vaudois (CHUV) - Service de néonatologie
    Lausanne, Switzerland
    Recruiting
Show 3 more locations
  • Luzerner Kantonsspital, Kinderspital
    Lucerne, Switzerland
    Recruiting
  • Ostschweizer Kinderspital & Neonatologie und Frauenklinik KSSG
    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
  • Email: anne.carrer@ukbb.ch
  • Phone: +4161 704 2853

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.