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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 8 Days and up |
| Sex | All |
| Enrollment | 750 (estimated) |
| Sponsor | University Children's Hospital Basel Academic / other |
| Locations | 9 sites (Aarau and 8 other locations) |
| Status | Recruiting |
| Started | July 12, 2025 |
| Main results expected | December 2029 |
| Study ends | December 2029 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT06954142 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
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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
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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
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Lung Ultrasound Score to predict BPD in very preterm babies
This study tests whether lung ultrasound scores in the first two weeks of life can predict which extremely preterm babies will develop bronchopulmonary dysplasia.
-
Caffeine in pregnancy: how the mother and baby handle it during delivery
This study tests how caffeine is processed in pregnant people and how much reaches the baby when given shortly before delivery.
-
IVIG for bronchopulmonary dysplasia in infants born at 28 weeks or earlier
This trial will try intravenous immunoglobulin (IVIG) given over five days to see if it helps very preterm infants (≤28 weeks) who show early signs of bronchopulmonary dysplasia.
-
High-energy DHA/ARA-enriched human milk in the first 2 weeks to lower lung problems in extremely preterm babies
This trial tests whether giving DHA/ARA-enriched, fortified human milk in the first 14 days after birth helps extremely preterm infants breathe easier and have better lung function.
-
Using IVIG to treat bronchopulmonary dysplasia in premature infants
This study is testing if a special immune treatment called IVIG can help premature babies with breathing problems caused by bronchopulmonary dysplasia feel better.
-
Comparing two IV lipid infusions for very preterm or very low birth weight infants
This study will try two types of intravenous lipid emulsions (mixed-oil vs soybean-oil) in extremely preterm or very low birth weight infants to see which better prevents bronchopulmonary dysplasia and supports growth and brain development.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.