Comparison of outcomes of single drug therapy versus dual drug therapy in the treatment of hemodynamically significant PDA
Phase 2
- Conditions
- Health Condition 1: Q250- Patent ductus arteriosus
- Registration Number
- CTRI/2024/05/066914
- Lead Sponsor
- Govind Choudhary
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Preterm neonates less than 32 week admitted in the NICU with hemodynamically significant PDA between 12 and 72 hours of life.
2. Written Informed parental or guardian consent obtained
Exclusion Criteria
1. Major lethal congenital malformations
2.Echocardiographic evidence of pulmonary hypertension.
3. IVH grade III or more
4. Platelet count less than 50,000/mm3
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome <br/ ><br>To determine Combined outcome of death and/ or BPD evaluated at thirty six weeks of Postmenstrual age. <br/ ><br> <br/ ><br>Timepoint: Thirty six weeks postmenstrual age.
- Secondary Outcome Measures
Name Time Method Secondary Outcome <br/ ><br>1.IVH Grade III or more <br/ ><br>2.NEC Stage II or more <br/ ><br>3.Ductal closure on day three and seven <br/ ><br>4.Duration of respiratory support.Timepoint: At discharge
Related Research Topics
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What molecular mechanisms underlie ibuprofen's efficacy in closing hemodynamically significant PDA in neonates?
How does the combination of ibuprofen and paracetamol compare to ibuprofen monotherapy in PDA treatment outcomes in low-resource NICUs?
Are there specific biomarkers that predict response to NSAID-based therapies for patent ductus arteriosus in preterm infants?
What are the potential adverse events associated with dual drug therapy (ibuprofen + paracetamol) for PDA in neonatal intensive care settings?
How does ibuprofen-based pharmacotherapy compare to other PDA treatment approaches like indomethacin or surgical ligation in terms of long-term neurodevelopmental outcomes?