Patent Ductus Arteriosus. Patent ductus arteriosus
Conditions
Interventions
Intervention 1: The control group was also given three doses of standard-regimen oral ibuprofen with initial dose of 10 mg/kg, followed by two doses of 5 mg/kg each, 24 and 48 hours later. Interventio
Hakim Pharmaceutical, Tehran, Iran, 75-HM-30) was administered to these infants. The first dose of high-dose regimen was 20 mg/kg and the second and third doses were 10 mg/kg . Wherever the ductus ar
Treatment - Drugs
The control group was also given three doses of standard-regimen oral ibuprofen with initial dose of 10 mg/kg, followed by two doses of 5 mg/kg each, 24 and 48 hours later
Intervention group consists of the ones who were treated with high dose-regimen of oral ibuprofen .Using a 24 hour interval, three doses of oral suspension (100 mg/5 ml
Sponsors
Dean Of Research Of Shiraz University Of Medical Science
Eligibility
Sex/Gender
All
Age
3 Days to 7 Days
Inclusion criteria
Inclusion criteria: Inclusion criteria: preterm infants with less than 37 weeks gestation and postnatal age of 3 to 7 days who will admitted at the neonatal intensive care unit of Shiraz Namazi and Hafez hospitals with clinical patent ductus arteriosus which was diagnosed by a pediatric cardiologist by using of Doppler echocardiography exclusion criteria includes:major congenital anomalies; congenital heart defect; persistent pulmonary hypertension;life-threatening infections; sever bleeding; decreased Urine output<1 cc/kg/hr; impaired renal function with a serum(Cr<1.8 mg/dl); platelet count<50000; hematuria; gastrointestinal bleeding
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Closure of patent ductus arteriosus by echocardiography. Timepoint: 3rd day of birth(before intervention) and 7th day of birth(after intervention). Method of measurement: Doppler echocardiography was performed with a MindrayDC-7 echocardiography machine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects like: decrease urine out put, gastrointestinal bleeding, impaired renal function, bleeding tendency and other drug's side effect. Timepoint: Daily clinical and laboratory evaluation before intervention till three days after intervention. Method of measurement: clinical evaluation and performing CBC,Cr, platlet, urine out put measurement. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr.Shahnaz Pourarian
Neonatology research center, Shiraz University Of Medical Science
Outcome results
None listed