Objective To test the hypothesis that oral paracetamol is non-inferior to oral ibuprofen in closing hemodynamically significant patent ductus arteriosus (hsPDA) with an a priori noninferiority (NI) margin of 15%. Study design Multicenter, randomized, controlled, NI trial conducted in level III neonatal intensive care units. Consecutively inborn preterm neonates of <32 weeks of gestation with hsPDA were included. Those with structural heart disease, major malformations, and contraindications for enteral feeding or for administration of study drugs were excluded. Interventions included oral paracetamol in the experimental arm and oral ibuprofen in the active control arm. The primary outcome was closure of hsPDA by 24 hours from the last dose of the study drug. Secondary outcome measures included closure of hsPDA by 24 hours after the first course of the study drug, rate of reopening after the first course, and adverse events associated with the study drug. Results Out of 1250 neonates screened, 161 were randomized. Oral paracetamol was noninferior to oral ibuprofen in closure of hsPDA by both per protocol analysis (62 [95.4%] vs 63 [94%]; relative risk [RR], 1.01 [95% CI, 0.94-1.1]; risk difference [RD], 1.4 [95% CI, À6 to 9]; P = .37) and intention-to-treat analysis (63 [89%] vs 65 [89%]; RR, 0.99 [95% CI, 0.89-1.12]; RD, À0.3 [95% CI, À11 to 10]; P = .47). All adverse events were comparable in the 2 study arms. Conclusions Oral paracetamol is noninferior to oral ibuprofen for the closure of hsPDA in preterm neonates of <32 weeks of gestation. No difference was observed in the adverse events studied.
<p class="abstract">This is a case report of isolated cryptococcosis in the operated mastoid cavity of an immunocompetent individual. A 24 year old immunocompetent male who underwent modified radical mastoidectomy presented to the OPD with complaints of otalgia and recurrent otorrhoea, not responding to regular medical line of treatment and aural toileting. Microscopy and culture of the ear dischrage revealed <em>Cryptococcus</em> <em>neoformans</em>. The patient was treated with oral and topical fluconazole and recovered completely. Although rare, cryptococcal mastoiditis should be considered even in an immunocompetent patient, as any delay in diagnosis and treatment can lead to fatal complications.</p>
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