Patent ductus arteriosus
Conditions
Interventions
Patients randomized to the expectative management arm will not receive any COXi
and PDA management in this group can be characterized as *watchful waiting*.
This is not a unique approach, since a re
Patent ductus arteriosus
Preterm infant
Randomized controlled trial
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: - Gestational age 1.5 mm and ductal (predominantly) left-to-right shunt - Signed informed consent obtained from parent(s) or representative(s)
Exclusion criteria
Exclusion criteria: - Contraindication for administration of cyclooxygenase-inhibitors (COXi) - Use of COXi prior to randomization - Persistent pulmonary hypertension (ductal right-to-left shunt *33% of cardiac cycle) - Congenital heart defect, other than PDA and/or PFO - Life-threatening congenital defects - Chromosomal abnormalities and/or congenital anomalies associated with abnormal neurodevelopmental outcome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the composite of: - Mortality at a postmenstrual age of = IIa) at a postmenstrual age of | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are short term sequela of cardiovascular failure, adverse effects during the stay in the hospital and long term neurodevelopmental consequences assessed at a corrected age of 2 years. Short term sequela of cardiovascular failure - Hypotension (defined as MABP | — |
Countries
Belgium, Netherlands
Outcome results
None listed