Health TrialsbyHealthPanel

Restricted Versus Liberal Fluid Intake for Prevention of Bronchopulmonary Dysplasia

ConditionBronchopulmonary Dysplasia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8+
SponsorUniversity Children's Hospital Basel

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Hospitalised preterm infants born before 30 weeks 0 days gestation

Signed informed consent for further research use of health-related data

Disqualifiers

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 design

Design model

Crossover

Treatments tested in this trial

  • Fluid restriction

    Other intervention

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

  • Liberal fluid intake

    Other intervention

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

Treatment groups

750 Participants
are divided into 2 treatment groups
Group A: Fluid restrictionExperimental treatment 1 intervention
Group B: Liberal fluid intakeActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Bronchopulmonary dysplasia (BPD)

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

Time frame
From enrolment to 36 weeks postmenstrual age

Secondary outcomes

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

Time frame
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

Time frame
From enrolment to 36 weeks postmenstrual age
3

Need of diuretics

Treatment with diuretics (days on diuretics)

Time frame
From enrolment to 36 weeks postmenstrual age
4

Need of corticosteroids

Systemic postnatal corticosteroids for prevention or treatment of bronchopulmonary dysplasia

Time frame
From enrolment to 36 weeks postmenstrual age

Other outcomes

1

Growth

Growth (weight, length, and head circumference z-score)

Time frame
from 36 weeks postmenstrual age, 6-12 and 18-24 months post-term
2

Respiratory outcome

Respiratory outcome as per Basel-Bern-Infant-Lung-Development cohort study questionnaire

Time frame
from 36 weeks postmenstrual age, 6-12 and 18-24 months post-term
3

Visits to the emergency

Visits to the emergency department from discharge to 6-12 months for any reason

Time frame
From discharge to 6-12 and 18-24 months
4

Neurodevelopmental outcome

Neurodevelopmental outcome as per PARCA-R questionnaire

Time frame
from enrolment to 18-24 months post-term

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Children's Hospital Basel

Lead sponsor

Swiss Neonatal Network

Collaborator

SwissPedNet

Collaborator

Source ClinicalTrials.gov
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