Status:
COMPLETED
Oral Nystatin Prophylaxis to Prevent Systemic Fungal Infection in Very Low Birth Weight Preterm Infants
Lead Sponsor:
Dr Cipto Mangunkusumo General Hospital
Conditions:
Fungal Infections Systemic
Eligibility:
All Genders
Up to 3 years
Phase:
PHASE4
Brief Summary
This study determines the effectiveness of oral nystatin as prophylaxis in order to prevent systemic fungal infection in very low birth weight preterm neonates. 47 participants received oral nystatin ...
Detailed Description
Oral nystatin is an effective and safe alternative fungal prophylaxis. Some previous studies (1 randomized controlled trial and 4 observational studies) showed that oral nystatin prophylaxis reduce fu...
Eligibility Criteria
Inclusion
- Gestational age \<= 32 weeks and/or birth weight \<=1500 grams
- 1 or more systemic fungal infection risk factors (antibiotic therapy, intravenous access, endotracheal tube, orogastric tube, urinary catheter, corticosteroid therapy, parenteral nutrition, theophylline therapy)
Exclusion
- Suspected of having necrotizing enterocolitis within 72 hours after birth, cyanotic congenital heart disease, chromosomal defects, or critical conditions whom were not expected to live more than 72 hours after birth
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT03390374
Start Date
October 1 2010
End Date
January 1 2013
Last Update
January 4 2018
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