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Early Versus Late Lactoferrin in Prevention of Neonatal Sepsis

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ClinicalTrials.gov Identifier: NCT02959229
Recruitment Status : Completed
First Posted : November 9, 2016
Last Update Posted : November 9, 2016
Sponsor:
Information provided by (Responsible Party):
Atef Nagy Mohamed, Ain Shams University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neonatal Sepsis Drug: Lactoferrin Drug: Placebo (for Lactoferrin) Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Official Title: Systematic Randomized , Single Blinded, Placebo-Controlled Trial of Early Versus Late Lactoferrin in Prevention of Neonatal Sepsis
Study Start Date : August 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
Experimental: Early Lactoferrin Group
Oral Bovine Lactoferrin 100 mg/day once starting on day 1 of life and continued for 4-6 weeks.
Drug: Lactoferrin
Other Name: Bovine Lactoferrin

Experimental: Late Lactoferrin Group
Oral Bovine Lactoferrin 100 mg/day once starting on day 3 of life and continued for 4-6 weeks.
Drug: Lactoferrin
Other Name: Bovine Lactoferrin

Active Comparator: Placebo Group
placebo in form of distilled water once starting on day 1 of life and continued for 4-6 weeks.
Drug: Placebo (for Lactoferrin)
placebo in form of distilled water




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Neonates with a < 37 weeks of gestation counting from the first day of the Last Menstrual Period.
  2. Preterm neonates are breast fed, artificially fed or on total parenteral nutrition.
  3. 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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02959229


Sponsors and Collaborators
Ain Shams University
Investigators
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Study Director: Ghada I Ghad, Professor Ain Shams University

Publications:
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Responsible Party: Atef Nagy Mohamed, clinical researcher, Ain Shams University
ClinicalTrials.gov Identifier: NCT02959229     History of Changes
Other Study ID Numbers: FMASU M.S 23/2016
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: November 9, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Atef Nagy Mohamed, Ain Shams University:
Late onset sepsis
Bovine Lactoferrin

Additional relevant MeSH terms:
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Sepsis
Toxemia
Neonatal Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Infant, Newborn, Diseases
Lactoferrin
Anti-Infective Agents