Bronchopulmonary DysplasiaRELIEFNCT06954142
Restricted Versus Liberal Fluid Intake for Prevention of Bronchopulmonary Dysplasia
A study testing Fluid restriction and Liberal fluid intake in people with Bronchopulmonary Dysplasia, run by University Children's Hospital Basel at 9 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 days and older
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- Fluid restriction and Liberal fluid intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 9 sitesSwitzerland
- Study dates
- 12 Jul 2025to Dec 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hospitalised preterm infants born before 30 weeks 0 days gestation
- Signed informed consent for further research use of health-related data
Who cannot join
- 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)
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Michel Schrutt contact
9 sites in 1 country
Switzerland9 sites, 9 recruiting
- Recruiting
Kantonsspital Aarau AG, Klinik für Kinder u. Jugendliche
Aarau, 5001
Philipp Meyer, KD Dr. med., +41 62 838 49 48, philipp.meyer@ksa.ch
Philipp Meyer, KD Dr. med.
- Recruiting
University Children's Hospital Basel (UKBB)
Basel, 4056
Sven Schulzke, Prof. MD, +41 61 5565486, sven.schulzke@ukbb.ch
Benjamin Stöcklin, PD MD, benjamin.stoecklin@ukbb.ch
- Recruiting
Inselspital Bern, Kinderklinik
Bern, 3010
André Kidszun, Prof. MD, +41 31 632 21 11, andre.kidszun@insel.ch
Marta Busso, MD, +41 76 2324427, marta.busso@insel.ch
- Recruiting
Kantonsspital Graubünden, Departement Kinder- und Jugendmedizin
Chur, 7000
Bjarte Rogdo, Dr. med., +41 81 256 6400, bjarte.rogdo@ksgr.ch
Bjarte Rogdo, MD
- Recruiting
Hôpitaux universitaires de Genève (HUG), Service de Néonatologie et Soins Intensifs
Geneva, 1205
Francisca Barcos Munoz, MD, +41 22 372 68 16, francisca.barcos@hug.ch
Dimitra Papsavva, MD, dimitra.papasavva@hug.ch
- Recruiting
Centre hospitalier universitaire vaudois (CHUV) - Service de néonatologie
Lausanne, 1011
Eric Giannoni, Assoc. Prof., +41 21 314 34 60, Eric.Giannoni@chuv.ch
Sébastien Joye, MD, +41 21 314 3464, Sebastien.Joye@chuv.ch
- Recruiting
Luzerner Kantonsspital, Kinderspital
Lucerne, 6000
Martin Stocker, Prof. MD, +41 (0)41 205 32 31, martin.stocker@luks.ch
Martin Stocker, Prof. MD
- Recruiting
Ostschweizer Kinderspital & Neonatologie und Frauenklinik KSSG
Sankt Gallen, 9000
André Birkenmaier, Dr.med., +41 (0)71 243 13 49, Andre.Birkenmaier@oks.ch
André Birkenmaier, MD
- Recruiting
UniversitätsSpital Zürich, Klinik für Neonatologie
Zurich, 8091
David Glauser, MD, +41 43 253 87 59, david.glauser@usz.ch
Dirk Bassler, Prof. MD, +41 44 255 11 11, dirk.bassler@usz.ch
About this study
Official title: Restricted Versus Liberal Fluid Intake for Prevention of Bronchopulmonary Dysplasia - RELIEF Trial. A Cluster-randomised Multiple Period Cross-over Trial.
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.
Read the detailed description
Complications of preterm birth remain the leading cause of death in children under five years of age worldwide, accounting for approximately one million deaths annually. Among the survivors, bronchopulmonary dysplasia (BPD) is the most common severe complication. BPD is a chronic lung disease characterized by prolonged need for respiratory support and oxygen therapy, poor postnatal growth, and long-term impairments in lung function and neurodevelopment.
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
- Bronchopulmonary Dysplasia
- Being tested
- Fluid restriction, Liberal fluid intake
- Keywords
- Fluid Restriction, Preterm Infants
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid restrictionOther
Fluid restriction strategy (fluid target 135 ±5 mL/kg/d)
Liberal fluid intakeOther
Liberal fluid intake strategy (fluid target 165 ± 5 mL/kg/d)
| Study group | Role | What they receive |
|---|---|---|
| Fluid restriction | Experimental | Fluid restriction strategy (fluid target 135 ±5 mL/kg/d). This is standard of care. Receives: Other: Fluid restriction |
| Liberal fluid intake | Active comparator | Liberal fluid intake strategy (fluid target 165 ± 5 mL/kg/d) in line with international best practice recommendations on nutrition. Receives: Other: Liberal fluid intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchopulmonary dysplasia (BPD)
Proportion of infants with BPD measured at 36 weeks postmenstrual age or prior death.
Measured: From enrolment to 36 weeks postmenstrual age
Secondary outcomes (11)
Complications of prematurity
Major complications of prematurity including necrotising enterocolitis ≥ Bell's stage 2, retinopathy of prematurity requiring treatment, patent ductus arteriosus requiring treatment, abnormal brain ultrasound, late onset sepsis
Measured: From enrolment to 36 weeks postmenstrual age
Days to reach full feeds
Days to reach full feeds defined as 150 ml/kg/d or being off parenteral nutrition
Measured: From enrolment to 36 weeks postmenstrual age
Need of diuretics
Treatment with diuretics (days on diuretics)
Measured: From enrolment to 36 weeks postmenstrual age
Need of corticosteroids
Systemic postnatal corticosteroids for prevention or treatment of bronchopulmonary dysplasia
Measured: From enrolment to 36 weeks postmenstrual age
Need of respiratory support
Duration of mechanical ventilation, non-invasive respiratory support, total positive pressure support, supplemental oxygen support, supplemental home oxygen, home ventilation
Measured: At first discharge home, on average 37 weeks postmenstrual age
Growth
difference in weight, length, and head circumference z-score at 36 weeks postmenstrual age and at birth, respectively
Measured: at birth and 36 weeks postmenstrual age
Daily caloric intake
Daily caloric intake from day 8 of life to 36 weeks postmenstrual age
Measured: From enrolment to 36 weeks postmenstrual age
Dehydration
Dehydration (sodium level ≥ 150 mmol/L plus clinical signs of dehydration)
Measured: From enrolment to 36 weeks postmenstrual age
Fluid overload
Fluid overload (sodium level ≤ 130 mmol/L plus clinical signs of fluid overload)
Measured: From enrolment to 36 weeks postmenstrual age
Age at discharge
Postmenstrual age at discharge home
Measured: At first discharge home, on average 37 weeks postmenstrual age
Tube feeding
Tube feeding at discharge home
Measured: At first discharge home, on average 37 weeks postmenstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start12 Jul 2025
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Pragmatic, registry-linked, multicentre, open-label, cluster-randomised, multiple period, cross-over, effectiveness trial
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital Basel
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Neonatal Network, SwissPedNet
- Responsible party
- Sponsor
- Investigators
- Sven Schulzke, Prof.MD, Principal investigator, University Children's Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954142
- Sponsor's protocol ID
- 2025-00321; ks22Schulzke
- Other IDs
- 2025
- Acronym
- RELIEF
- Status last verified
- Oct 2026
- First submitted
- 15 Apr 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No