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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Fungal Infections Systemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The participants is randomly allocated into 2 study groups (nystatin group and control group) during study period

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Nystatin Oral

Intervention Type DRUG

Nystatin oral suspension

Control group

Sterile water 1 mL three times a day for oral hygiene

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nystatin Oral

Nystatin oral suspension

Intervention Type DRUG

Other Intervention Names

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Mycostatin

Eligibility Criteria

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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

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No