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

NCT ID: NCT05848492

Last Updated: 2023-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2021-10-31

Brief Summary

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.

Conditions

Invasive Candidiases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Prophylactic Fluconazole

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).

Group Type: EXPERIMENTAL

Fluconazole

Intervention Type: DRUG

Fluconazole will be given for prevention of invasive candidiasis in preterm and very low birthweight babies.

placebo group

Normal Saline 2cc given intravenously

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

0.9% Saline 2cc intravenous will be given to preterm babies in placebo group.

Interventions

Fluconazole

Fluconazole will be given for prevention of invasive candidiasis in preterm and very low birthweight babies.

Intervention Type: DRUG

Saline

0.9% Saline 2cc intravenous will be given to preterm babies in placebo group.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 3 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Services Institute of Medical Sciences, Pakistan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Muhammad Tauseef Omer

Post-graduate resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

M Tauseef Omer, MBBS FCPS Pediatrics

Role: PRINCIPAL_INVESTIGATOR

Services Hospital, Lahore

Locations

Services Hospital Lahore

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

FluconazolePreterm1

Identifier Type: -

Identifier Source: org_study_id