Comparison of feeding or not feeding the premature babies when they are given oral drug ibuprofen and evaluate the time to reach full feeds in two groups.
- Conditions
- Health Condition 1: P29- Cardiovascular disorders originating in the perinatal period
- Registration Number
- CTRI/2020/03/023945
- Lead Sponsor
- okmanyaTilak Municipal Medical College General Hospital Mumbai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 126
All preterm babies less than 30 weeks of gestation with hemodynamically significant patent ductus arteriosus (PDA) on trearment with oral Ibuprofen.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method