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IRCT20201222049802N2 IRCT 2021-03-15 Zanjan University of Medical Sciences Oral nystatin prophylaxis to prevent of candida colonization in premature infant with weigth less than 1500 gram in Neonatal Intensive care Unit Oral nystatin prophylaxis to prevent of candida colonization in premature infant with weigth less than 1500 gram in Neonatal Intensive care Unit 2021-04-04 anticipated 106 Complete https://irct.ir/trial/54207 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Infants are randomly divided into one of two groups, the nystatin group and the control group. Infants in both groups are similar in age, sex, gestational age, weight, and other anthropometric findings. Infants in the nystatin group receive 100,000 UI / ml, 0.5 ml intraorally and 0.5 ml via the urogastric tube three times a day from the nystatin oral suspension of Emad Darman Pars Company. The control group did not receive antifungal prophylaxis, Randomization description: Random sequence through a table of random numbers. 3 candida colonization. Intervention 1: Intervention group: Intervention group: Infants born in Ayatollah Mousavi Hospital in Zanjan or admitted from other hospitals in the province who are in the first 72 hours of life and are admitted to the neonatal intensive care unit and have a gestational age less than 32w or birth weight less than 1500gr, From the oral suspension of nystatin of Emad Darman Pars Company, they receive 100,000 UI / ml, 1ml (0.5 ml into the oral cavity and 0.5 ml through the urogastric tube) three times a day. The mouth and rectum are prepared for smear and fungal culture and sent to the laboratory of Mousavi Hospital in Zanjan for analysis. Intervention 2: Control group: Control group: Intervention group: Infants born in Ayatollah Mousavi Hospital in Zanjan or admitted from other hospitals in the province who are in the first 72 hours of life and are hospitalized in the neonatal intensive care unit and have a gestational age less than 32w or birth weight less than 1500gr, the control group does not receive antifungal prophylaxis. After a week, a swab is prepared from the oral mucosa and rectum for smear and culture of the fungus and sent to the laboratory of Mousavi Hospital in Zanjan for analysis. 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 The release schedule will be announced soon.
public Asghar Marzban
Ayatollah Mousavi Hospital, Gavazang Road, Above Shahid Sabouti Boulevard, zanjan, iran.
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3342 0651 Drmarzban@zums.ac.ir Zanjan University of Medical Sciences scientific Asghar Marzban
Ayatollah Mousavi Hospital, Gavazang Road, Above Shahid Sabouti Boulevard, zanjan, iran.
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3342 0651 Drmarzban@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) infants born in the first 72 hours of life birth weight less than 1500gram gestational age less than 32 weeks who are hospitalized in the neonatal intensive care unit 1 day 3 days Both severe abnormalities chromosomal abnormalities severe sepsis Congenital heart disease Intraventricular hemorrage disseminated intravascular coagulation Thrush congenital disorders requiring surgery Fungal infections proven by blood or urine culture require treatment with appropriate antifungal drugs such as amphotericinCommunity Verified icon Parents' dissatisfaction with the infant's participation in the study P37.5 Neonatal candidiasis Prevention Other Intervention group: Intervention group: Infants born in Ayatollah Mousavi Hospital in Zanjan or admitted from other hospitals in the province who are in the first 72 hours of life and are admitted to the neonatal intensive care unit and have a gestational age less than 32w or birth weight less than 1500gr, From the oral suspension of nystatin of Emad Darman Pars Company, they receive 100,000 UI / ml, 1ml (0.5 ml into the oral cavity and 0.5 ml through the urogastric tube) three times a day. The mouth and rectum are prepared for smear and fungal culture and sent to the laboratory of Mousavi Hospital in Zanjan for analysis. Control group: Control group: Intervention group: Infants born in Ayatollah Mousavi Hospital in Zanjan or admitted from other hospitals in the province who are in the first 72 hours of life and are hospitalized in the neonatal intensive care unit and have a gestational age less than 32w or birth weight less than 1500gr, the control group does not receive antifungal prophylaxis. After a week, a swab is prepared from the oral mucosa and rectum for smear and culture of the fungus and sent to the laboratory of Mousavi Hospital in Zanjan for analysis. Gestetional age. Timepoint: Week. Method of measurement: The number of weeks that have elapsed since the last menstrual period. Birth weight. Timepoint: Birth. Method of measurement: Weighing the baby. Type of delivery(Natural vaginal delivery or cesarean section). Timepoint: at birth. Method of measurement: Get a history and file. Premature rupture of the membrane. Timepoint: rupture of the membrane>18houres. Method of measurement: Get a history and file. Use of broad-spectrum antibiotics (third-generation cephalosporins and carbapenems). Timepoint: One week after birth. Method of measurement: Get a history and file. Receive invasive respiratory ventilation. Timepoint: One week after birth. Method of measurement: Get a history and file. Oral culture and smear for fungi. Timepoint: one week after birth. Method of measurement: laboratory report. Rectal culture and smear for fungi. Timepoint: One week after birth. Method of measurement: laboratory report. Zanjan University Of Medical Science Approved 2020-12-16 Ethics committee of Zanjan University of Medical Sciences Ayatollah Mousavi Hospital, Above Shahid Sabouti Boulevard, Gavazang Road, Zanjan, Iran. Zanjan Zanjan Iran (Islamic Republic of)