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IRCT20210908052412N1 IRCT 2021-10-27 Tabriz University of Medical Sciences Efficacy of Fluconazole in comparison with Nystatin in the prevention of fungal infections in very low birth weight infants Efficacy of Fluconazole in comparison with Nystatin in the prevention of fungal infections in very low birth weight infants 2021-06-10 anticipated 50 Complete https://irct.ir/trial/58580 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the block randomization method is used with blocks of sizes six and four. The website https://www.sealedenvelope.com is used to create a randomization list. The blocks are randomly selected using this website and given to a researcher who is not involved in choosing the type of drug. Each random chain generated contains a unique code for concealment. The drug regimen is placed in envelopes according to random chains, and after sealing it on the envelopes, the specific number created by the site is written and the envelopes are randomly placed in a box. a box, Blinding description: In this study, only newborns are blind (due to the condition of the infant and the parents do not know what drug is given to the infant) and do not know the type of medication received. 3 Fungal Infections, Premature. Intervention 1: Intervention group: Receiving injectable fluconazole (made by Sina Daru, Iran) at a dose of 3 mg/kg twice a week and in case of peripheral or central vein rupture, continue with oral fluoxonazole 6 mg / kg twice a week for 4 weeks . Intervention 2: Intervention group: Receiving oral nystatin (Emad Darman Pars, Iran) 100,000 units (1 ml) in suspension every eight hours for four weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Leila Asgarzadeh
No. 23, Forozanfar St, Gisha St
Tehran Iran (Islamic Republic of) 1446754471 0098 23046253 dr.l.asgarzadeh@gmail.com Tabriz University of Medical Sciences scientific Leila Asgarzadeh
No. 23, Forozanfar St, Gisha St
Tehran Iran (Islamic Republic of) 1446754471 +98 21 2304 6253 dr.l.asgarzadeh@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Premature newborns with gestational age less than 32 weeks Newborn in the age range of 0 to 3 days Birth weight less than 1500 gr Parents' consent to participate in the study 1 day 3 days Both Neonates with congenital anomalies Newborns with shock P37.5 Neonatal candidiasis Treatment - Drugs Treatment - Drugs Intervention group: Receiving injectable fluconazole (made by Sina Daru, Iran) at a dose of 3 mg/kg twice a week and in case of peripheral or central vein rupture, continue with oral fluoxonazole 6 mg / kg twice a week for 4 weeks . Intervention group: Receiving oral nystatin (Emad Darman Pars, Iran) 100,000 units (1 ml) in suspension every eight hours for four weeks Fungal infections. Timepoint: Baseline and end of study (after 4 weeks). Method of measurement: Bactec, cerebrospinal fluid (CSF) or urine culture. Tabriz University of Medical Sciences Approved 2021-05-03 Ethics committee of Tabriz University of Medical Sciences 3rd Floor, Central Building, Azadi St, Golgasht St Tabriz East Azarbaijan Iran (Islamic Republic of)