Oral Nystatin Prophylaxis to Prevent Systemic Fungal Infection in Very Low Birth Weight Preterm Infants
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|ClinicalTrials.gov Identifier: NCT03390374|
Recruitment Status : Completed
First Posted : January 4, 2018
Last Update Posted : January 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fungal Infections Systemic||Drug: Nystatin Oral||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||95 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The participants is randomly allocated into 2 study groups (nystatin group and control group) during study period|
|Masking:||None (Open Label)|
|Official Title:||Oral Nystatin Prophylaxis to Prevent Systemic Fungal Infection in Very Low Birth Weight Preterm Infants: a Randomized Controlled Trial|
|Actual Study Start Date :||October 2010|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||January 2013|
Experimental: Nystatin group
Nystatin oral 1 mL (0.5 mL coated in oral cavity and the rest was given through orogastric tube) three times a day
Drug: Nystatin Oral
Nystatin oral suspension
Other Name: Mycostatin
No Intervention: Control group
Sterile water 1 mL three times a day for oral hygiene
- Fungal colonization [ Time Frame: 1 to 6 weeks ]Weekly oropharyngeal and rectal fungal surveillance results are evaluated. Colonization is considered positive if yeast cells were found on either oral or rectal specimen
- Systemic fungal infection [ Time Frame: 1 to 6 weeks ]Culture of blood, cerebrospinal fluid, deep tissue, or urine is evaluated in participants with symptoms/signs of systemic infection. Proven systemic fungal infection is defined as a positive blood, cerebrospinal fluid, deep tissue, or urine culture (> 10.000 or more colony forming unit/mL from sterile bladder catheterization or suprapubic aspiration)
- Mortality rates [ Time Frame: 1 to 6 weeks ]Fungal and overall related mortality rates
- Nystatin-related adverse drug reactions [ Time Frame: 1 to 6 weeks ]Any side effects of nystatin as reported in references
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390374
|Principal Investigator:||Lily Rundjan, MD||Dr Cipto Mangunkusumo General Hospital|