Clinical trial NCT03390374: Oral Nystatin Prophylaxis to Prevent Systemic Fungal Infection in Very Low Birth Weight Preterm Infants
Official title: Oral Nystatin Prophylaxis to Prevent Systemic Fungal Infection in Very Low Birth Weight Preterm Infants: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fungal Infections Systemic
Keywords: Nystatin
Fungal colonization
Systemic fungal infections
Lead sponsor: Dr Cipto Mangunkusumo General Hospital
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 95
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants is randomly allocated into 2 study groups (nystatin group and control group) during study period
Primary purpose: PREVENTION

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

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Fungal colonization
timeFrame: 1 to 6 weeks
measure: Systemic fungal infection
timeFrame: 1 to 6 weeks
Secondary outcomes:
measure: Mortality rates
timeFrame: 1 to 6 weeks
measure: Nystatin-related adverse drug reactions
timeFrame: 1 to 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Dr Cipto Mangunkusumo General Hospital
name: Lily Rundjan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rundjan L, Wahyuningsih R, Oeswadi CA, Marsogi M, Purnamasari A. Oral nystatin prophylaxis to prevent systemic fungal infection in very low birth weight preterm infants: a randomized controlled trial. BMC Pediatr. 2020 Apr 17;20(1):170. doi: 10.1186/s12887-020-02074-0.