Patent Ductus Arteriosus. Patent ductus arteriosus
Conditions
Interventions
Intervention 1: Intervention group: Oral ibuprofen with a dose of 10 mg per kg on the first day and then 5 mg per kilogram in the next two doses at intervals of 24 and 48 hours. Intervention 2: Interv
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
1 Days to 15 Days
Inclusion criteria
Inclusion criteria: Premature infants with hemodynamicaiy significant Patent Ductus Arteriosus Premature infant with a gestational age of less than 37 weeks and a birth weight of less than or equal to 2500 grams
Exclusion criteria
Exclusion criteria: Ductal dependent congenital Heart diseases Life threatening infections Syndromic manifestations Persistent Pulmonary Hypertention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Closure of PDA in preterm infants. Timepoint: Echocardiography at 3 to 15 days of birth (before starting treatment), 4 days after starting treatment. Method of measurement: Echocardiographicaly. | — |
Secondary
| Measure | Time frame |
|---|---|
| Requires a second course of medical treatment. Timepoint: The day after the first course of medical treatment. Method of measurement: Ecocardiographicaly.;Need for surgical treatment. Timepoint: The day after the second course of medical treatment. Method of measurement: Ecocardiographicaly.;Increased serum creatinine. Timepoint: Any time after initiation of medical treatment. Method of measurement: Physical examination & laboratory tests.;Incidence of pulmonary hemorrhage. Timepoint: Any time after initiation of medical treatment. Method of measurement: Physical examination & CXR.;Incidence of intraventricular hemorrhage. Timepoint: Any time after initiation of medical treatment. Method of measurement: Physical examination & brain sonography.;Incidence of gastrointestinal bleeding. Timepoint: Any time after initiation of medical treatment. Method of measurement: Physical examination & laboratory tests.;Incidence of necrotizing enterocolitis. Timepoint: Any time after initiation of medical treatment. Method of measurement: Clinical and Paraclinical Examination.;Impaired liver function tests. Timepoint: Any time after initiation of medical treatment. Method of measurement: Clinical examination and laboratory tests.;Hyperbilirubinemia. Timepoint: Any time after initiation of medical treatment. Method of measurement: Clinical examination and laboratory tests. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactZeinab Harif Nashtifani
Tehran University of Medical Sciences
Outcome results
None listed