Oral nystatin prophylaxis to prevent of candida colonization in premature infant with weigth less than 1500 gram in Neonatal Intensive care Unit

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20201222049802N2

Enrollment

106

Registered

2021-03-15

Start date

2021-04-04

Completion date

Unknown

Last updated

2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

candida colonization. Neonatal candidiasis

Interventions

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

Eligibility

Sex/Gender

All

Age

1 Days to 3 Days

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAsghar Marzban

Zanjan University of Medical Sciences

Drmarzban@zums.ac.ir+98 24 3342 0651

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026