Oral nystatin prophylaxis to prevent systemic fungal infection in very low birth weight preterm infants: a randomized controlled trial
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Lily Rundjan1, Retno Wahyuningsih2, Chrissela Anindita Oeswadi3
1Division of Neonatology, Department of Pediatrics, Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo Hospital, Jalan Diponegoro 71, DKI Jakarta, 10430, Indonesia. lily_kartono69@yahoo.co.uk.
Insights
Oral nystatin effectively reduced fungal colonization in very low birth weight (VLBW) preterm infants. While showing a potential protective effect against systemic fungal infection (SFI), the difference in SFI rates was not statistically significant.
Area of Science:
- Neonatalogy
- Infectious Diseases
- Pharmacology
Background:
- Systemic fungal infection (SFI) is a major cause of death in very low birth weight (VLBW) preterm infants.
- Early SFI diagnosis is difficult due to nonspecific symptoms, making prophylaxis essential.
- This study investigated oral nystatin's prophylactic efficacy in VLBW preterm infants.
Purpose of the Study:
- To evaluate the effectiveness of oral nystatin for preventing SFI in VLBW preterm infants.
- To assess the impact of nystatin prophylaxis on fungal colonization rates.
- To determine the safety profile of oral nystatin in this vulnerable population.
Main Methods:
- A prospective, randomized controlled trial was conducted in a neonatal intensive care unit.
- VLBW infants (gestational age ≤ 32 weeks and/or birth weight ≤ 1500g) at risk for fungal infection were randomized to receive oral nystatin or a placebo (sterile water).
- Fungal colonization, SFI incidence, mortality, and adverse drug reactions were monitored over a six-week period.
Main Results:
- Fungal colonization was significantly lower in the nystatin group (29.8%) compared to the control group (56.3%).
- Five cases of SFI occurred, all in the control group, though this difference was not statistically significant (p=0.056).
- No significant difference in overall mortality or nystatin-related adverse drug reactions was observed between the groups.
Conclusions:
- Oral nystatin is a safe and effective prophylactic agent for reducing fungal colonization in VLBW preterm infants.
- Nystatin demonstrated a potential protective effect against SFI, warranting further investigation.
- The study supports the use of nystatin for antifungal prophylaxis in high-risk VLBW infants.
Background:
Systemic fungal infection (SFI) is one of leading causes of morbidity and mortality in very low birth weight (VLBW) preterm infants. Because early diagnosis of SFI is challenging due to nonspecific manifestations, prophylaxis becomes crucial. This study aimed to assess effectiveness of oral nystatin as an antifungal prophylaxis to prevent SFI in VLBW preterm infants.
Methods:
A prospective, open-labelled, randomized controlled trial was performed in a neonatal intensive care unit (NICU) of an academic hospital in Indonesia. Infants with a gestational age ≤ 32 weeks and/or birth weight of ≤ 1500 g with risk factors for fungal infection were assessed for eligibility and randomized to either an intervention group (nystatin) or control group. The intervention group received 1 ml of oral nystatin three times a day, and the control group received a dose of 1 ml of sterile water three times a day. The incidence of fungal colonization and SFI were observed and evaluated during the six-week study period. Overall mortality rates and nystatin-related adverse drug reactions during the study period were also documented.
Results:
A total of 95 patients were enrolled. The incidence of fungal colonization was lower among infants in nystatin group compared to those in control group (29.8 and 56.3%, respectively; relative risk 0.559; 95% confidence interval 0.357-0.899; p-value = 0.009). There were five cases of SFI, all of which were found in the control group (p-value = 0.056). There was no difference in overall mortality between the two groups. No adverse drug reactions were noted during the study period.
Conclusions:
Nystatin is effective and safe as an antifungal prophylactic medication in reducing colonization rates in the study population. Whilst the use of nystatin showed a potential protective effect against SFI among VLBW preterm infants, there was no statistical significant difference in SFI rates between groups.
Trial Registration:
NCT03390374. Registered 4 January 2018 - Retrospectively registered.
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