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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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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

relief@ukbb.ch

9 sites in 1 country

Switzerland9 sites, 9 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

    Recruiting

Other trials in Switzerland

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.

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 groups in NCT06954142
Study groupRoleWhat they receive
Fluid restrictionExperimentalFluid restriction strategy (fluid target 135 ±5 mL/kg/d). This is standard of care.
Receives: Other: Fluid restriction
Liberal fluid intakeActive comparatorLiberal 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.

  1. 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)
  1. 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

  2. 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

  3. Need of diuretics

    Treatment with diuretics (days on diuretics)

    Measured: From enrolment to 36 weeks postmenstrual age

  4. Need of corticosteroids

    Systemic postnatal corticosteroids for prevention or treatment of bronchopulmonary dysplasia

    Measured: From enrolment to 36 weeks postmenstrual age

  5. 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

  6. 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

  7. Daily caloric intake

    Daily caloric intake from day 8 of life to 36 weeks postmenstrual age

    Measured: From enrolment to 36 weeks postmenstrual age

  8. Dehydration

    Dehydration (sodium level ≥ 150 mmol/L plus clinical signs of dehydration)

    Measured: From enrolment to 36 weeks postmenstrual age

  9. Fluid overload

    Fluid overload (sodium level ≤ 130 mmol/L plus clinical signs of fluid overload)

    Measured: From enrolment to 36 weeks postmenstrual age

  10. Age at discharge

    Postmenstrual age at discharge home

    Measured: At first discharge home, on average 37 weeks postmenstrual age

  11. 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.

  1. First posted1 May 2025
  2. Study start12 Jul 2025
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

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)
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

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