preterm, newborn, patent ductus arteriosus, neonatology te vroeg geborene, open ductus Botalli, neonatologie
Conditions
Interventions
Patients randomized to the expectative management arm will not receive any cyclooxygenase-inhibition and PDA management in this group can be characterized as 'watchful waiting'.
When the patient is a
Sponsors
Radboud university medical center
Nijmegen, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: - Gestational age 1.5 mm - Signed informed consent obtained from parent(s) or representative(s)
Exclusion criteria
Exclusion criteria: - Contraindication to administration of COX-inhibitors - PPHN (ductal right-to-left shunting ≥ 33% of cardiac cycle) - Congenital heart defects, other than PDA and or PFO - Life-threatening congenital defects - Chromosomal abnormalities and/or congenital anomalies associated with an abnormal neurodevelopmental outcome - Use of COX-inhibitors or paracetamol prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The composite of: - mortality at a postmenstrual age of = IIa) at a postmenstrual age of <= 36 completed weeks, and/or - bronchopulmonary dysplasia, defined as the need for supplemental oxygen at a postmenstrual age of 36 completed weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Short term sequelae of cardiovascular failure, adverse effects during the stay in the hospital and long-term neurodevelopmental consequences assessed at a corrected age of 2 years. | — |
Contacts
Public ContactWillem P. de Boode
Radboudumc Amalia Children's Hospital P.O.Box 9101, 6500 HB Nijmegen (804)
Outcome results
None listed