Health Condition 1: P293- Persistent fetal circulation
Conditions
Sponsors
Aditya Kurade
Eligibility
Inclusion criteria
Inclusion criteria: Gestational age more than 26 weeks to less than 37 weeks. Birth weight more than 500 grams and less than 2000 grams. Echocardiographic Evidence of Hemodynamic significant PDA - PDA diameter more than 1.5 mm, PDA doppler flow pattern left to right (Growing and pulsatile pattern), LA/AO ratio more than 1.5 .
Exclusion criteria
Exclusion criteria: Chromosomal anomalies suspected or proven Significant congenital malformation Complex congenital heart disease Severe Birth asphyxia Severe Persistent pulmonary hypertension (PPHN) Previously treated for PDA Contraindications for Ibuprofen administration (any of following) - Acute kidney injury (Oliguria urine output less than 1 ml/kg/24 hours and or Raised serum creatinine level more than 1 mg/dl), Increased hepatic enzyme (two fold raised than baseline level), severe hyperbilirubinemia (serum bilirubin nearing exchange level), Thrombocytopenia (Platelet count less than 50,000/cumm), Acute or suspected Necrotising Enterocolitis (As per Bell s staging), acute bleeding - Pulmonary hemorrhage, Intraventricular hemorrhage, Gastrointestinal bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemodynamic significant PDA resolution or PDA closureTimepoint: Baseline, 5 days and 10 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Any Adverse drug effectsTimepoint: Till 7 days after completion of drug therapy | — |
Countries
India
Contacts
Public ContactAditya Vijay Kurade
Bharati Vidyapeeth (Deemed to be University) Medical college and Hospital, Sangli.
Outcome results
None listed