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

Fungal Infections Systemic Clinical Trial

Official title:

Oral Nystatin Prophylaxis to Prevent Systemic Fungal Infection in Very Low Birth Weight Preterm Infants: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03390374
• Other study ID #: 434/PT02.FK/ETIK/2010
• Status: Completed
• Phase: Phase 4
• First received: December 27, 2017
• Last updated: December 27, 2017
• Start date: October 2010
• Est. completion date: January 2013

Study information

• Verified date: December 2017
• Source: Dr Cipto Mangunkusumo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: January 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Days

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Communicable Diseases
• Fungal Infections Systemic
• Infection
• Mycoses
• Sepsis

Intervention

Drug:
• Nystatin Oral
Nystatin oral suspension

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr Cipto Mangunkusumo General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fungal colonization	Weekly oropharyngeal and rectal fungal surveillance results are evaluated. Colonization is considered positive if yeast cells were found on either oral or rectal specimen	1 to 6 weeks
Primary	Systemic fungal infection	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)	1 to 6 weeks
Secondary	Mortality rates	Fungal and overall related mortality rates	1 to 6 weeks
Secondary	Nystatin-related adverse drug reactions	Any side effects of nystatin as reported in references	1 to 6 weeks