Effect of Administration of Combined Enteral Lactoferrin and Probiotic On Invasive Fungal Infections In Preterm Neonates

Phase 1

Completed

• Conditions: Fungal Infection
• Interventions: Drug: Lactoferrin Bovine; Combination Product: Lactoferrin Bovine and probiotics; Other: Placebo

• Registration Number: NCT05283278
• Lead Sponsor: Ain Shams University

Brief 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

Detailed 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).

Study Timeline

• Study First Submitted: 2017-10-17
• Study Start: 2020-02-10
• Primary Completion: 2021-03-27
• Study Completion: 2021-04-27
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-12
• Last Update Submitted: 2022-03-12
• Study First Posted: 2022-03-16
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 80 preterm
• ≤ 36 weeks gestational age
• >/ = 72 hours of life

Read More

Exclusion Criteria

1. Nothing per os
2. Congenital anomalies.
3. Suspected inborn error of metabolism.
4. Prophylaxis antifungal drugs

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lactoferrin Bovine group	Lactoferrin Bovine	Group A (20 preterm neonates) which will receive lactoferrin (100mg/day)
Lactoferrin Bovine with probiotics group	Lactoferrin Bovine and probiotics	Group B (20 preterm neonates) which will receive lactoferrin (100mg/day) in combination with the probiotic
Placebo group	Placebo	Group C (40 preterm neonates) which is a placebo group.

Primary Outcome Measures

Name	Time	Method
Number of participants with invasive fungal infection (IFI)	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Mortality in each group	12 months	Define the number of mortality in each group
Days on inotropic support in each group	12 months	Define how many days required for inotropic support in each group
Days on mechanical ventilation in each group	12 months	Define how many days required for mechanical ventilation support in each group
Days of NICU admission in each group	12 monthes	Define how many days patients in each group were admitted in the NICU
Number of participants with Necrotizing enterocolitis in each group	12 months	Define the rate of NEC occurrence in each group
Number of patients who received packed RBC in each group	30 days	The number of patients who received packed RBC in each group from time of enrollment till the 30th day of life

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt