Patent Ductus Arteriosus
Conditions
Keywords
Patent Ductus Arteriosus, Paracetamol, Ibuprofen, Preterm infant
Brief summary
The purpose of this study is to determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants.
Detailed description
To determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants. Eighty preterm infants with patent ductus arteriosus will be enrolled in this prospective-randomized study. Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h or oral paracetamol 15 mg/kg per dose every 6 hours. One of the following echocardiographic criteria of a duct size \>1.5 mm, a left atrium-to-aorta ratio \>1.5, left-to-right shunting of blood, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition signs of patent ductus arteriosis determined the need of treatment.
Interventions
DRUGOral paracetamol
Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours for 3 days.
DRUGOral ibuprofen
Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.
Sponsors
Zekai Tahir Burak Women's Health Research and Education Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
2 Days to 10 Days
Healthy volunteers
No
Inclusion criteria
* Birth weight below 1250 gram * Diagnosed patent ductus arteriosus by Echocardiographic examination
Exclusion criteria
* Accompanied other congenital cardiac anomalies * Urine output of less than 1 ml/kg/h during the preceding 8 h, * Serum creatinine level \>1.6 mg/dl, * Platelet count \<60,000/mm3, * Liver failure, * Hyperbilirubinemia requiring exchange transfusion * Severe intracranial bleeding (Grade III - IV) * Intestinal abnormality and necrotising enterocolitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy and Safety of Oral Paracetamol Versus Oral Ibuprofen | Until discharge | To compare the closure rate of patent ductus arteriosus after oral paracetamol or oral ibuprofen treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long term effects of oral paracetamol versus oral ibuprofen treatment in preterm infants | corrected 36 weeks or until discharge | Long term effects such as ROP, BPD,IVH, duration of respiratory support and hospitalization are going to be evaluated. |
Countries
Turkey (Türkiye)
Outcome results
None listed