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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05283278
Other study ID # Pediatrics Dep-ASU
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 10, 2020
Est. completion date April 27, 2021

Study information

Verified date March 2022
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The risk for invasive fungal infections is high in very low birth weight (VLBW) infants (< 1500 g) and highest for infants born at the youngest gestational ages who survive past the immediate postnatal period. Invasive fungal infections (IFIs) represent an increasing cause of severe morbidity and mortality in most neonatal intensive care units. Lactoferrin (LF) is secreted by epithelial cells into exocrine fluids: seminal fluid, tears, saliva, uterine secretions, and milk. LF is involved in innate immunity mechanisms with several documented anti-infective properties, including antifungal activity. Probiotics are microorganisms that are believed to provide health benefits when consumed. It is possible to adopt measures to modify the flora in our bodies and to replace the harmful microbes by useful microbes. There are certain commercially available strains of probiotic bacteria from the Bifido bacterium and Lactobacillus genera when taken by mouth in daily doses possess treatment efficacy


Description:

Bovine LF alone or in combination of probiotics (Lactobacillus Delbrueckii and Lactobacillus Fermentum) can be used in prevention of invasive fungal infection in preterm neonates admitted to the NICU. So, this randomized interventional study aimed at evaluation of the efficacy and safety of enterally administered bovine LF alone or in combination of probiotics (Lactobacillus Delbrueckii and Lactobacillus Fermentum) in comparison to placebo in preterm neonates, through studying blood culture for fungal infection at enrollment, day 7, 14, 21 and 28 using Sabouraud agar for detecting Candida species and Hichrome agar to detect other fungal types ( primary outcome), and to compare length of hospital stay (LOS), use and duration of drug intake as antibiotics and inotropes, use and duration of mechanical ventilation, rate of increase of enteral feeding, time to reach full enteral intake, signs of feeding intolerance, complete blood count (CBC), C reactive protein (CRP), packed red blood cell transfusion (PRBCs) and mortality between the 3 groups as (secondary outcome).


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date April 27, 2021
Est. primary completion date March 27, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 30 Days
Eligibility Inclusion Criteria: - 80 preterm - = 36 weeks gestational age - >/ = 72 hours of life Exclusion Criteria: 1. Nothing per os 2. Congenital anomalies. 3. Suspected inborn error of metabolism. 4. Prophylaxis antifungal drugs

Study Design


Intervention

Drug:
Lactoferrin Bovine
Lactoferrin granules (Pravotin®) in a dose of 100 mg /kg/day starting from birth to the 30th day of life for neonates in group A
Combination Product:
Lactoferrin Bovine and probiotics
Lactoferrin granules (Pravotin®) in a dose of 100 mg /kg/day in combination with the probiotic Lactobacillus Delbrueckii and Lactobacillus Fermentum (Lacteol fort®) given in a dose of 5 billions starting from birth to the 30th day of life for neonates in group B
Other:
Placebo
Placebo will be given starting from birth to the 30th day of life for neonates in group C.

Locations

Country Name City State
Egypt Ain Shams University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with invasive fungal infection (IFI) Efficacy of enteral lactoferrin either alone or in combination with the probiotic Lactobacillus Delbrueckii and Lactobacillus Fermentum in the prevention of invasive fungal infections in preterm infants through analyzing the incidence rates of invasive fungal infection (IFI) in all groups using Sabouraud agar for detecting Candida species and Hichrome agar to detect other fungal types. 12 months
Secondary Number of patients who received packed RBC in each group The number of patients who received packed RBC in each group from time of enrollment till the 30th day of life 30 days
Secondary Days on inotropic support in each group Define how many days required for inotropic support in each group 12 months
Secondary Days on mechanical ventilation in each group Define how many days required for mechanical ventilation support in each group 12 months
Secondary Days of NICU admission in each group Define how many days patients in each group were admitted in the NICU 12 monthes
Secondary Number of participants with Necrotizing enterocolitis in each group Define the rate of NEC occurrence in each group 12 months
Secondary Mortality in each group Define the number of mortality in each group 12 months
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