Restricted Versus Liberal Fluid Intake for Prevention of Bronchopulmonary Dysplasia
NCT ID: NCT06954142
Last Updated: 2025-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
750 participants
INTERVENTIONAL
2025-07-12
2029-12-31
Brief Summary
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Detailed Description
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Despite advancements in neonatal care, BPD is the most common chronic lung disease in infancy and associated with increased mortality, repeated hospitalisation throughout childhood, impaired lung function up into adulthood, and long-term neurodevelopmental impairment. The incidence of BPD has remained stable over the past 15 years. This is likely due to the improved survival of extremely preterm infants, who are at the highest risk for BPD.
A key feature of evolving BPD is the accumulation of interstitial pulmonary edema, which reduces lung compliance and increases the need for respiratory support, thereby perpetuating a cycle of lung damage.
Currently, diuretics are sometimes used to manage pulmonary edema in preterm infants. While they can improve lung function in the short term, they come with potential risks including bone demineralization, nephrotoxicity, electrolyte imbalances, and impaired growth.
As a potentially safer alternative, fluid restriction is sometimes used to prevent or manage pulmonary edema. It is hypothesized to improve lung mechanics and reduce the need for respiratory support, without the adverse effects associated with medications. However, there is no robust evidence on optimal fluid targets in these patients.
SwissNeoNet, consisting of all nine Swiss NICUs, is a mandatory national registry, where data on all infants born before 32 weeks of gestation and/or with a birth weight \< 1501 g are collected. Fluid management practices vary among Swiss neonatal intensive care units (NICUs) following international guidelines recommending 135 to 180 mL/kg/day of fluids. This variation may contribute to the differing rates of BPD and mortality observed across centers, but fluid intake is not routinely captured in SwissNeoNet data, making it difficult to assess its impact.
In summary, although fluid restriction shows potential as a simple and low-risk intervention to reduce the incidence of BPD, current evidence is insufficient to support its routine use. There is a clear need for a robust, contemporary, and pragmatic trial to evaluate whether fluid restriction, started after the first week of life, can safely and effectively reduce the incidence of BPD or death in very preterm infants.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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Fluid restriction
Fluid restriction strategy (fluid target 135 ±5 mL/kg/d). This is standard of care.
Fluid restriction
Fluid restriction strategy (fluid target 135 ±5 mL/kg/d)
Liberal fluid intake
Liberal fluid intake strategy (fluid target 165 ± 5 mL/kg/d) in line with international best practice recommendations on nutrition.
Liberal fluid intake
Liberal fluid intake strategy (fluid target 165 ± 5 mL/kg/d)
Interventions
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Fluid restriction
Fluid restriction strategy (fluid target 135 ±5 mL/kg/d)
Liberal fluid intake
Liberal fluid intake strategy (fluid target 165 ± 5 mL/kg/d)
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent for further research use of health-related data
Exclusion Criteria
* 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)
8 Days
ALL
No
Sponsors
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Swiss Neonatal Network
NETWORK
University Children's Hospital Basel
OTHER
Responsible Party
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Principal Investigators
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Sven Schulzke, Prof.MD
Role: PRINCIPAL_INVESTIGATOR
University Children's Hospital Basel, UKBB
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-00321; ks22Schulzke
Identifier Type: -
Identifier Source: org_study_id
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