Oral Nystatin Prophylaxis to Prevent Systemic Fungal Infection in Very Low Birth Weight Preterm Infants

Last updated: December 27, 2017
Sponsor: Dr Cipto Mangunkusumo General Hospital
Overall Status: Completed

Phase

4

Condition

Soft Tissue Infections

Treatment

N/A

Clinical Study ID

NCT03390374
434/PT02.FK/ETIK/2010
  • Ages < 3
  • All Genders

Study 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 and 48 participants received sterile water as part of oral hygiene.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Gestational age <= 32 weeks and/or birth weight <=1500 grams

  • 1 or more systemic fungal infection risk factors (antibiotic therapy, intravenousaccess, endotracheal tube, orogastric tube, urinary catheter, corticosteroid therapy,parenteral nutrition, theophylline therapy)

Exclusion

Exclusion Criteria:

  • Suspected of having necrotizing enterocolitis within 72 hours after birth, cyanoticcongenital heart disease, chromosomal defects, or critical conditions whom were notexpected to live more than 72 hours after birth

Study Design

Total Participants: 95
Study Start date:
October 01, 2010
Estimated Completion Date:
January 31, 2013

Study 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 fungal colonization and decrease risk of systemic fungal infection in very low birth weight infants.

Nystatin is a non-absorbable antifungal agent with minimal side effects that works by binding on the major component of fungus cell membrane and causes death of the fungus. Its efficacy as fungal prophylaxis is comparable with Fluconazole but does not linked to drug-induced liver injury.

To determine this effectivity, we recruit eligible neonates who are admitted in our neonatal intensive care unit and randomly assign them into 2 groups once noted written parental consent. One group is given nystatin via oral and/or orogastric tube and the other group only receives sterile water as part of oral hygiene. Weekly fungal surveillance cultures (oropharyngeal and rectal) are done to evaluate colonization. Further examinations (blood/cerebrospinal fluid/deep tissue/urine culture) are done once noted clinical signs of systemic fungal infections.

Data analysis is conducted with intent-to treat approach. Significance testing is done by chi-square or fisher's exact test as needed.