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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03390374
Recruitment Status : Completed
First Posted : January 4, 2018
Last Update Posted : January 4, 2018
Information provided by (Responsible Party):
Lily Rundjan, Dr Cipto Mangunkusumo General Hospital

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.

Condition or disease Intervention/treatment Phase
Fungal Infections Systemic Drug: Nystatin Oral Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
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)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Drug Information available for: Nystatin

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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

  2. 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)

Secondary Outcome Measures :
  1. Mortality rates [ Time Frame: 1 to 6 weeks ]
    Fungal and overall related mortality rates

  2. Nystatin-related adverse drug reactions [ Time Frame: 1 to 6 weeks ]
    Any side effects of nystatin as reported in references

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03390374

Sponsors and Collaborators
Dr Cipto Mangunkusumo General Hospital
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Principal Investigator: Lily Rundjan, MD Dr Cipto Mangunkusumo General Hospital
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Responsible Party: Lily Rundjan, Lily Rundjan, MD, Neonatologist, Dr Cipto Mangunkusumo General Hospital Identifier: NCT03390374    
Other Study ID Numbers: 434/PT02.FK/ETIK/2010
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lily Rundjan, Dr Cipto Mangunkusumo General Hospital:
Fungal colonization
Systemic fungal infections
Additional relevant MeSH terms:
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Communicable Diseases
Birth Weight
Body Weight
Systemic Inflammatory Response Syndrome
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action