Patent ductus arteriosus (PDA)
Conditions
Brief summary
Primary outcome: Composite of pre-discharge mortality or any grade BPD, defined as need for oxygen or positive pressure respiratory support at 36 weeks postmenstrual age.
Detailed description
i) PDA treatment success, defined as PDA closure or becoming insignificant [diameter <1.5 mm]. ii) Renal or hepatic dysfunction occurring within 7 days of treatment initiation, as defined under exclusion criteria. iii) Further exposure to PDA treatments (these will be as per units’ standard practice, not part of this study). iv) Procedure for PDA closure. v)Mortality, vi) severity of BPD at 36 weeks postmenstrual age using Jensen’s criteria recently shown to be the definition which best predicted early childhood morbidities (grade 1, nasal cannula ≤2 L/min; grade 2, nasal cannula >2 L/min or noninvasive positive airway pressure; grade 3, invasive mechanical ventilation), vii) NEC ≥ stage 2A. viii) Duration (days) of invasive or non-invasive respiratory support. ix) Diuretic use during NICU stay. x) Exposure to postnatal steroids. xi) Sepsis during NICU stay
Interventions
DRUGPedea 5 mg/ml solution for injection
Sponsors
Royal College Of Surgeons In Ireland
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: Composite of pre-discharge mortality or any grade BPD, defined as need for oxygen or positive pressure respiratory support at 36 weeks postmenstrual age. | — |
Secondary
| Measure | Time frame |
|---|---|
| i) PDA treatment success, defined as PDA closure or becoming insignificant [diameter <1.5 mm]. ii) Renal or hepatic dysfunction occurring within 7 days of treatment initiation, as defined under exclusion criteria. iii) Further exposure to PDA treatments (these will be as per units’ standard practice, not part of this study). iv) Procedure for PDA closure. v)Mortality, vi) severity of BPD at 36 weeks postmenstrual age using Jensen’s criteria recently shown to be the definition which best predicted early childhood morbidities (grade 1, nasal cannula ≤2 L/min; grade 2, nasal cannula >2 L/min or noninvasive positive airway pressure; grade 3, invasive mechanical ventilation), vii) NEC ≥ stage 2A. viii) Duration (days) of invasive or non-invasive respiratory support. ix) Diuretic use during NICU stay. x) Exposure to postnatal steroids. xi) Sepsis during NICU stay | — |
Countries
Ireland
Outcome results
None listed