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

NCT ID: NCT05283278

Last Updated: 2022-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-10
• Study Completion Date: 2021-04-27

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).

Conditions

Fungal Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Lactoferrin Bovine group

Group A (20 preterm neonates) which will receive lactoferrin (100mg/day)

Group Type: ACTIVE_COMPARATOR

Lactoferrin Bovine

Intervention Type: DRUG

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

Lactoferrin Bovine with probiotics group

Group B (20 preterm neonates) which will receive lactoferrin (100mg/day) in combination with the probiotic

Group Type: ACTIVE_COMPARATOR

Lactoferrin Bovine and probiotics

Intervention Type: COMBINATION_PRODUCT

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

Placebo group

Group C (40 preterm neonates) which is a placebo group.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo will be given starting from birth to the 30th day of life for neonates in group C.

Interventions

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

Intervention Type: DRUG

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

Intervention Type: COMBINATION_PRODUCT

Placebo

Placebo will be given starting from birth to the 30th day of life for neonates in group C.

Intervention Type: OTHER

Other Intervention Names

Pravotin®; Pravotin® plus Lacteol fort

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 30 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Hebatallah A Shaaban, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hebatallah A Shaaban, MD

Role: STUDY_DIRECTOR

Doctor

Locations

Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Pediatrics Dep-ASU

Identifier Type: -

Identifier Source: org_study_id