Services Hospital Lahore
Lahore, Punjab Province, Pakistan
NCT Number: NCT05848492
Invasive fungal infection is detecting candida species in blood, cerebrospinal fluid, or urine. Clinical signs of invasive candidiasis may include lethargy, temperature instability, feeding intolerance, apnea, hypotension, respiratory distress, abdominal distension, and thrombocytopenia. Fungal infection has been associated with an increased risk of retinopathy of prematurity and chronic lung disease. Preterm and low birth weight infants have an immature immune system that predisposes them to infections with bacteria, viruses, and fungi. These infants usually require prolonged admission in the neonatal unit and there is often a need for the administration of broad-spectrum antibiotics which predisposes them to colonization with fungi that may invade to cause systemic disease8. Other risk factors for the development of invasive fungal infection include endotracheal intubation, abdominal surgery, the presence of a central venous catheter, administration of H2 antagonists, and steroids. Infection with Candida species is the third most common cause of bloodstream infection in premature infants. Mortality in preterm infants due to invasive candidiasis is around 20% and can be as high as 50% in infants weighing <1500g at birth. Invasive candidiasis is the second most common infectious cause of death in extremely preterm infants. The present study was conducted to determine the incidence of invasive candidiasis among preterm and very low birth weight infants in our neonatal unit and to evaluate the efficacy of prophylactic fluconazole in preventing invasive fungal infection. Based on the results of the present study institutional guidelines may be designed in our neonatal unit relating to antifungal prophylaxis in preterm and very low birth weight infants.
Looking for future studies?
Notify Me1 hour–3 day
All sexes
Interventional
Phase 3
Lahore, Punjab Province, Pakistan
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fluconazole will be given for prevention of invasive candidiasis in preterm and very low birthweight babies.
0.9% Saline 2cc intravenous will be given to preterm babies in placebo group.
Time frame: 2 weeks
Positive blood, cerebrospinal fluid, or urine culture for candida species will be regarded as invasive candidiasis.
Services Institute of Medical Sciences, Pakistan
Other Gov
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04148287
Bacterial Infections and Mycoses, Candida Infection
Alberton, Gauteng, South Africa
View Trial DetailsNCT03667690
Bacterial Infections and Mycoses, Candidemia
Birmingham, Alabama, United States
View Trial DetailsNCT03468803
Bacterial Infections and Mycoses, Candidiasis
Graz, Stmk, Austria
View Trial DetailsNCT03717623
Bacterial Infections and Mycoses, Candidiasis
Parkville, Victoria, Australia
View Trial Details