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Completed

NCT Number: NCT04094597

Safety and Efficacy of Oral Bovine Lactoferrin

Oral lactoferrin versus Placebo will be given to preterm neonates

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Key information

Conditions

Neonatal SEPSIS Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

1 day–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Ayman

Asyut, Assuit, 71111, Egypt

About this study

200 patient were included in the study , one hundred received oral placebo in the form of 2 ml saline , the other 100 preterm neonates received oral lactoferrin with monitoring of C-reactive protein , different cultures, complete blood count on day 7 and after one month.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

All neonates born at Cairo university hospital NICU

Exclusion criteria

  • Neonatal deaths before 3 days postnatal .
  • Neonates with underlying gastrointestinal problems that prevent oral intake.
  • Neonates with major congenital anomalies .
  • Neonates with severe hypoxic ischemic encephaloapathy .
  • Neonates whose parents refuse to participate.

Treatment and study plan

Lactoferrin

Drug

lactoferrin is given orally in comparsion to placebp

Other names: Pravotin sachets

Placebos

Drug

placebp is given in 2 ml saline

Other names: saline

Primary outcomes

  1. Change in mortality rate of neonatal sepsis in preterm neonate

    Time frame: one year

    Neonates will be assessed by C-reactive protein and different cultures to identify Neonatal sepsis

  2. Number of Preterm Neonates who will have long term Complication after one month of regular use of Lactoferrin

    Time frame: one year

    Neonates will be assessed for long term complication as necrotizing enterocolitis , retinoapathy of prematurity and bronchopulmonary dysplasia

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Kasr El Aini Hospital

Registry information

Official study title

Effectivness and Safety of Oral Bovine Lactoferrin in Neonatal Sepsis and Necrotizing Enterocolitis and Its Effect on Anaemia of Prematurity

Acronym: Lactoferrin

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Sep 19, 2019
Registry last updated
Sep 19, 2019

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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