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

NCT03390374 Phase 4 COMPLETED

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.

Details

Lead sponsor	Dr Cipto Mangunkusumo General Hospital
Phase	Phase 4
Status	COMPLETED
Enrolment	95
Start date	2010-10
Completion	2013-01

Conditions

• Fungal Infections Systemic

Interventions

• Nystatin Oral

Primary outcomes

• Fungal colonization — 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 — 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)