Efficacy of Prophylactic Fluconazole Therapy in Preterm and Very Low Birth Weight Neonates in Preventing Invasive Fungal Infection.

Services Institute of Medical Sciences, Pakistan

Status and phase: Completed; Phase 3

Conditions: Invasive Candidiases

Treatments: Drug: Saline; Drug: Fluconazole

Study type: Interventional

Funder types: Other

Identifiers

NCT05848492

FluconazolePreterm1

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 1 hour to 3 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Preterm babies born less than 34 weeks of gestation
• very low birth weight babies (weighing < 1500 g at birth)
• Babies <72 hours of age

Exclusion criteria

• Babies >72 hours of life
• Syndromic babies
• Babies with suspected metabolic disorders

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups, including a placebo group

Prophylactic Fluconazole

Experimental group

Description:

12 mg/Kg loading dose of fluconazole given intravenously followed by 6 mg/Kg every 48 hours till 14 days of life, and then 6 mg/kg/day thereafter, for a total duration of 6 weeks (42 days).

Treatment:

Drug: Fluconazole

placebo group

Placebo Comparator group

Description:

Normal Saline 2cc given intravenously

Treatment:

Drug: Saline