Trial reportBMC pediatrics2020
Oral nystatin prophylaxis to prevent systemic fungal infection in very low birth weight preterm infants: a randomized controlled trial.
Trial report in BMC pediatrics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03390374 (Oral Nystatin Prophylaxis to Prevent Systemic Fungal Infection in Very Low Birth Weight Preterm Infants), which is not on this map. Cited by 11 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Oral Nystatin Prophylaxis to Prevent Systemic Fungal Infection in Very Low Birth Weight Preterm Infants: a Randomized Controlled Trial
Who cites it
11 citing papers in PubMed, 18 citations in OpenAlex.
- Randomized controlled clinical trial of the impact of combined application of rhamnosus probiotics and oral nystatin on the colonization of intestinal Candida albicans in low birth weight neonates <2,500 grams.GMS hygiene and infection control · 2026Article
- A 10-Year Study of Neonatal Sepsis from Tuen Mun Hospital, Hong Kong.Pathogens (Basel, Switzerland) · 2025Article
- Addressing the silent threat: managing invasiveFrontiers in pediatrics · 2025Review
- Article
- Invasive Candida Infections in Neonatal Intensive Care Units: Risk Factors and New Insights in Prevention.Pathogens (Basel, Switzerland) · 2024Review
- Comparing Fluconazole and Nystatin as Antifungal Prophylactics in Very Low Birth Weight Infants: A Randomized Clinical Trial.Oman medical journal · 2024Article
- Neonatal invasive candidiasis in low- and middle-income countries: Data from the NeoOBS study.Medical mycology · 2023Observational
- Risk Factors, Diagnosis, and Treatment of Neonatal Fungal Liver Abscess: A Systematic Review of the Literature.Life (Basel, Switzerland) · 2023Review
- [Recent research on pharmacological prevention strategies for invasive fungal infection in preterm infants].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2022Review
- Evaluation of Physically and/or Chemically Modified Chitosan Hydrogels for Proficient Release of Insoluble Nystatin in Simulated Fluids.Gels (Basel, Switzerland) · 2022Article
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSystemic 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.
methodsA 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.
resultsA 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.
conclusionsNystatin 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 registrationNCT03390374. Registered 4 January 2018 - Retrospectively registered.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.