Restricted Versus Liberal Fluid Intake for Prevention of Bronchopulmonary Dysplasia

NCT06954142 | Recruiting DMC

• 1 other identifier: 2025-00321; ks22Schulzke
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 9

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.

Conditions

Bronchopulmonary Dysplasia

Keywords

Fluid Restriction; Preterm Infants

Outcome Measures

Primary Outcomes (1)

• Bronchopulmonary dysplasia (BPD)

  Proportion of infants with BPD measured at 36 weeks postmenstrual age or prior death.

  From enrolment to 36 weeks postmenstrual age

Secondary Outcomes (11)

• Complications of prematurity

  From enrolment to 36 weeks postmenstrual age

• Days to reach full feeds

  From enrolment to 36 weeks postmenstrual age

• Need of diuretics

  From enrolment to 36 weeks postmenstrual age

• Need of corticosteroids

  From enrolment to 36 weeks postmenstrual age

• Need of respiratory support

  At first discharge home, on average 37 weeks postmenstrual age

Other Outcomes (4)

• Growth

  from 36 weeks postmenstrual age, 6-12 and 18-24 months post-term

• Respiratory outcome

  from 36 weeks postmenstrual age, 6-12 and 18-24 months post-term

• Visits to the emergency

  From discharge to 6-12 and 18-24 months

Study Arms (2)

Fluid restriction

EXPERIMENTAL

Fluid restriction strategy (fluid target 135 ±5 mL/kg/d). This is standard of care.

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.

Other: Liberal fluid intake

Interventions

Fluid restriction OTHER

Fluid restriction strategy (fluid target 135 ±5 mL/kg/d)

Fluid restriction

Liberal fluid intake OTHER

Liberal fluid intake strategy (fluid target 165 ± 5 mL/kg/d)

Liberal fluid intake

Eligibility Criteria

• Age: 8 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalised preterm infants born before 30 weeks 0 days gestation
• Signed informed consent for further research use of health-related data

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Children's Hospital Basel: lead
• Swiss Neonatal Network: collaborator

Study Sites (9)

Kantonsspital Aarau AG, Klinik für Kinder u. Jugendliche

Aarau, 5001, Switzerland

RECRUITING

University Children's Hospital Basel (UKBB)

Basel, 4056, Switzerland

RECRUITING

Inselspital Bern, Kinderklinik

Bern, 3010, Switzerland

RECRUITING

Kantonsspital Graubünden, Departement Kinder- und Jugendmedizin

Chur, 7000, Switzerland

RECRUITING

Hôpitaux universitaires de Genève (HUG), Unité de Néonatologie

Geneva, 1205, Switzerland

RECRUITING

Centre hospitalier universitaire vaudois (CHUV) - Service de néonatologie

Lausanne, 1011, Switzerland

RECRUITING

Luzerner Kantonsspital, Kinderspital

Lucerne, 6000, Switzerland

RECRUITING

Ostschweizer Kinderspital & Neonatologie und Frauenklinik KSSG, Perinatalzentrum St. Gallen

Sankt Gallen, 9006, Switzerland

RECRUITING

UniversitätsSpital Zürich, Klinik für Neonatologie

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Sven Schulzke, Prof.MD

  University Children's Hospital Basel, UKBB

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Carrer

CONTACT

+4161 704 2853; anne.carrer@ukbb.ch

Michel Schrutt

CONTACT

relief@ukbb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic, registry-linked, multicentre, open-label, cluster-randomised, multiple period, cross-over, effectiveness trial

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: May 1, 2025
• Study Start: July 12, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

CH (9)