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Completed

NCT Number: NCT02959229

Early Versus Late Lactoferrin in Prevention of Neonatal Sepsis

The present study was designed to evaluate the effectiveness of oral lactoferrin in prevention of neonatal sepsis with comparison early (1st day) versus late (48-72 hours) Lactoferrin administration, Secondary aim was to study effect of Lactoferrin administration on serum Ferritin and follow up long term outcome (Bronchopulmonary dysplasia, retinopathy of prematurity and necrotizing enterocolitis.

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Key information

About this study

This study was carried out on 180 preterm neonates(< 37 weeks of gestation counting from the first day of the Last Menstrual Period and confirmed by Ballard score) admitted to the Neonatal Intensive Care Units of Ain Shams University Hospitals in the period from August 2014 to December 2015.

Enrolled subjects were further randomly subdivided into three groups according to the dose regimen of Lactoferrin supplementation.

  • Group A: (60 preterm neonates) who received oral Lactoferrin supplementation in a dose of 100 mg/day starting on day 1 and continue for 4-6 weeks.
  • Group B: (60 preterm neonates) who received oral Lactoferrin supplementation in a dose of 100 mg/day starting on day 3 (48hrs-72hrs) of life and continue for 4-6 weeks.
  • Group C: (60 preterm neonates) who match the subjected neonates, received placebo in form of distilled water.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Neonates with a < 37 weeks of gestation counting from the first day of the Last Menstrual Period.
  • Preterm neonates are breast fed, artificially fed or on total parenteral nutrition.
  • Preterm neonates born in, or referred to our Neonatal Intensive Care Unit in the first day of life free from infection and not fed.

Exclusion criteria

  • Neonates with underlying gastrointestinal problems that prevent oral intake.
  • Neonates with predisposing conditions that profoundly affect growth and development (chromosomal abnormalities, structural brain anomalies, severe congenital abnormalities).
  • Neonates with a family background of cow milk allergy.
  • Neonates who will not have the chance to complete the study time (who will be referred to another hospitals).
  • Neonates with early onset sepsis.
  • Neonates whose parents decline to participate.

Treatment and study plan

Lactoferrin

Drug

Other names: Bovine Lactoferrin

Placebo (for Lactoferrin)

Drug

placebo in form of distilled water

Primary outcomes

  1. Evaluate the effectiveness of oral Lactoferrin in prevention of neonatal sepsis according to Tollner score, hematological scoring system (HSS) and positive blood culture.

    Time frame: 4-6 weeks of life

  2. Compare early (1st day) versus late (48-72 hours) Lactoferrin administration on neonatal sepsis according to Tollner score, hematological scoring system (HSS) and positive blood culture

    Time frame: 4-6 weeks of life

Secondary outcomes

  1. Effect of Lactoferrin supplementation on long term complications

    Time frame: 4-6 weeks of life

    Long term complications as:

    Broncho-Pulmonary Dysplasia using clinical symptoms and signs and chest X ray findings.

    Retinopathy of Prematurity using the International Classification of Retinopathy of Prematurity (ICROP).

    Necrotizing Enterocolitis using Modified Bell's criteria for staging Necrotizing Enterocolitis.

  2. any reported side effects for Bovine Lactoferrin

    Time frame: 4-6 weeks of life

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Systematic Randomized , Single Blinded, Placebo-Controlled Trial of Early Versus Late Lactoferrin in Prevention of Neonatal Sepsis

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Nov 9, 2016
Registry last updated
Nov 9, 2016

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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