Clinical trial NCT05283278: Effect of Administration of Combined Enteral Lactoferrin and Probiotic On Invasive Fungal Infections In Preterm Neonates
Official title: Effect of Administration of Combined Enteral Lactoferrin and Probiotic On Invasive Fungal Infections In Preterm Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fungal Infection
Keywords: Lactoferrin
Probiotic
Preterm
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with invasive fungal infection (IFI)
timeFrame: 12 months
Secondary outcomes:
measure: Number of patients who received packed RBC in each group
timeFrame: 30 days
measure: Days on inotropic support in each group
timeFrame: 12 months
measure: Days on mechanical ventilation in each group
timeFrame: 12 months
measure: Days of NICU admission in each group
timeFrame: 12 monthes
measure: Number of participants with Necrotizing enterocolitis in each group
timeFrame: 12 months
measure: Mortality in each group
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Doctor
name: Hebatallah A Shaaban, MD
role: STUDY_DIRECTOR
References: