Efficacy of Fluconazole in comparison with Nystatin in the prevention of fungal infections in very low birth weight infants

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210908052412N1

Enrollment

Registered

2021-10-27

Start date

2021-06-10

Completion date

Unknown

Last updated

2021-11-01

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

Conditions

Fungal Infections, Premature. Neonatal candidiasis

Interventions

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 f

Eligibility

Sex/Gender

All

Age

1 Days to 3 Days

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: Neonates with congenital anomalies Newborns with shock

Design outcomes

Primary

Measure	Time frame
Fungal infections. Timepoint: Baseline and end of study (after 4 weeks). Method of measurement: Bactec, cerebrospinal fluid (CSF) or urine culture.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactLeila Asgarzadeh

Tabriz University of Medical Sciences

dr.l.asgarzadeh@gmail.com0098 23046253

Outcome results

None listed

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