CTRI/2020/03/023945
Completed
未知
Comparison of enteral feeding versus no feeding in preterm babies less than 30 weeks of gestation on time to reach full feeds during the treatment of patent ductus arteriosus with oral Ibuprofen - DAFNI Trial
okmanyaTilak Municipal Medical College General Hospital Mumbai0 sites126 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: P29- Cardiovascular disorders originating in the perinatal period
- Sponsor
- okmanyaTilak Municipal Medical College General Hospital Mumbai
- Enrollment
- 126
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All preterm babies less than 30 weeks of gestation with hemodynamically significant patent ductus arteriosus (PDA) on trearment with oral Ibuprofen.
Exclusion Criteria
- •1\.Contraindications for the use of ibuprofen (active bleeding, especially intracranial hemorrhage within 48 hours or gastrointestinal bleeding, thrombocytopenia(platelet count \<60000/mm3, suspected NEC,significant impairment of renal function with serum creatinine \> 1\.5 mg/dl)
- •2\.Congenital heart disease in which patency of the ductus arteriosus is necessary for satisfactory pulmonary or systemic blood flow
- •3\.Major congenital anomalies.
- •4\.Chromosomal anomalies
- •5\.Congenital or acquired gastrointestinal anomalies
- •6\.Prior episodes of necrotizing enterocolitis or intestinal perforation
- •7\.Severe shock requiring \> 2 Inotropes for hypotension at the time of entry
- •8\.Treatment of PDA after first week of life
- •9\.Babies on maximal enteral nutrition \> 60 ml/kg/ day
Outcomes
Primary Outcomes
Not specified
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