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Completed

NCT Number: NCT05283278

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

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

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Key information

Conditions

Fungal Infection Bacterial Infections and Mycoses Female Urogenital Diseases and Pregnancy Complications Infections Mycoses Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 day–30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ain Shams University

Cairo, 11381, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Nothing per os
  • Congenital anomalies.
  • Suspected inborn error of metabolism.
  • Prophylaxis antifungal drugs

Treatment and study plan

Lactoferrin Bovine

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

Other names: Pravotin®

Lactoferrin Bovine and probiotics

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

Other names: Pravotin® plus Lacteol fort

Placebo

Other

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

Primary outcomes

  1. Number of participants with invasive fungal infection (IFI)

    Time frame: 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 outcomes

  1. Number of patients who received packed RBC in each group

    Time frame: 30 days

    The number of patients who received packed RBC in each group from time of enrollment till the 30th day of life

  2. Days on inotropic support in each group

    Time frame: 12 months

    Define how many days required for inotropic support in each group

  3. Days on mechanical ventilation in each group

    Time frame: 12 months

    Define how many days required for mechanical ventilation support in each group

  4. Days of NICU admission in each group

    Time frame: 12 monthes

    Define how many days patients in each group were admitted in the NICU

  5. Number of participants with Necrotizing enterocolitis in each group

    Time frame: 12 months

    Define the rate of NEC occurrence in each group

  6. Mortality in each group

    Time frame: 12 months

    Define the number of mortality in each group

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 16, 2022
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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