Restricted Versus Liberal Fluid Intake for Prevention of Bronchopulmonary Dysplasia
- Conditions
- Bronchopulmonary Dysplasia
- Registration Number
- NCT06954142
- Lead Sponsor
- University Children's Hospital Basel
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 750
- Hospitalised preterm infants born before 30 weeks 0 days gestation
- Signed informed consent for further research use of health-related data
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Bronchopulmonary dysplasia (BPD) From enrolment to 36 weeks postmenstrual age Proportion of infants with BPD measured at 36 weeks postmenstrual age or prior death.
- Secondary Outcome Measures
Name Time Method Complications of prematurity From enrolment to 36 weeks postmenstrual age 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
Need of respiratory support At first discharge home, on average 37 weeks postmenstrual age Duration of mechanical ventilation, non-invasive respiratory support, total positive pressure support, supplemental oxygen support, supplemental home oxygen, home ventilation
Days to reach full feeds From enrolment to 36 weeks postmenstrual age Days to reach full feeds defined as 150 ml/kg/d or being off parenteral nutrition
Need of diuretics From enrolment to 36 weeks postmenstrual age Treatment with diuretics (days on diuretics)
Need of corticosteroids From enrolment to 36 weeks postmenstrual age Systemic postnatal corticosteroids for prevention or treatment of bronchopulmonary dysplasia
Growth at birth and 36 weeks postmenstrual age difference in weight, length, and head circumference z-score at 36 weeks postmenstrual age and at birth, respectively
Daily caloric intake From enrolment to 36 weeks postmenstrual age Daily caloric intake from day 8 of life to 36 weeks postmenstrual age
Dehydration From enrolment to 36 weeks postmenstrual age Dehydration (sodium level ≥ 150 mmol/L plus clinical signs of dehydration)
Fluid overload From enrolment to 36 weeks postmenstrual age Fluid overload (sodium level ≤ 130 mmol/L plus clinical signs of fluid overload)
Age at discharge At first discharge home, on average 37 weeks postmenstrual age Postmenstrual age at discharge home
Tube feeding At first discharge home, on average 37 weeks postmenstrual age Tube feeding at discharge home
Trial Locations
- Locations (8)
Kantonsspital Aarau AG, Klinik für Kinder u. Jugendliche
🇨🇭Aarau, Switzerland
Inselspital Bern, Kinderklinik
🇨🇭Bern, Switzerland
Kantonsspital Graubünden, Departement Kinder- und Jugendmedizin
🇨🇭Chur, Switzerland
Hôpitaux universitaires de Genève (HUG), Unité de Néonatologie
🇨🇭Genève, Switzerland
Luzerner Kantonsspital, Kinderspital
🇨🇭Luzern, Switzerland
Ostschweizer Kinderspital & Neonatologie und Frauenklinik KSSG, Perinatalzentrum St. Gallen
🇨🇭St. Gallen, Switzerland
UniversitätsSpital Zürich, Klinik für Neonatologie
🇨🇭Zürich, Switzerland
University Children's Hospital Basel UKBB
🇨🇭Basel, Switzerland