Prematurity patent ductus arteriosus Bronchopulmonary dysplasia patent ductus arteriosus bronchopulmonary dysplasia paracetamol ibuprofen
Conditions
Interventions
Paracetamol dose = 15 mg/kg/dose every 6 hr for 12 doses.,Ibuprofen dose = 10 mg/kg/dose every 24 hr for 3 doses
Experimental Drug,Active Comparator Drug
Paracetamol for PDA closure,Ibuprofen
Sponsors
Siriraj Hospital
Eligibility
Sex/Gender
All
Age
0 Months to 0 Years
Inclusion criteria
Inclusion criteria: Comparing incidence of chronic lung disease in infants GA<=28 weeks with hemodynamically significant PDA and receive ibuprofen or paracetamol within the first 72 hours.
Exclusion criteria
Exclusion criteria: 1. Lethal anomalies 2. Receives postnatal steroid 3. Hypoxic ischemic encephalopathy 4. Hydrops fetalis 5. Septic shock 6. Intestinal obstruction 7. Jaundice requiring exchange transfusion 8. PDA dependent congenital heart diseases 9. Fetal diagnosis of renal anomalies 10. IVH grade >=2 11. Thrombocytopenia upper normal limit 14. Maternal age < 18 years old 15. Attending physician refuse to let infant participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chronic lung disease, Bronchopulmonary dysplasia at post conceptual age 36 weeks Oxygen challenge test | — |
Secondary
| Measure | Time frame |
|---|---|
| Neurodevelopment corrected age 18 and 24 months Numeric rating scale,PDA closure at day of life 7 echcordiogram | — |
Countries
Thailand
Contacts
Public ContactBuranee Yangthara
Siriraj Hospital
Outcome results
None listed